ReferenceCitation: Inoue Y, Suda T, Kitamura H, Okamoto M, Azuma A, Inase N, Kuwana M, Makino S, Nishioka Y, Ogura T, Takizawa A, Ugai H, Stowasser S, Schlenker-Herceg R, Takeuchi T. Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial. Respir Med. 2021 Oct;187:106574. doi: 10.1016/j.rmed.2021.106574. Epub 2021 Aug 12.

family: Inoue

full_name: Yoshikazu Inoue

given: Yoshikazu

family: Suda

full_name: Takafumi Suda

given: Takafumi

family: Kitamura

full_name: Hideya Kitamura

given: Hideya

family: Okamoto

full_name: Masaki Okamoto

given: Masaki

family: Azuma

full_name: Arata Azuma

given: Arata

family: Inase

full_name: Naohiko Inase

given: Naohiko

family: Kuwana

full_name: Masataka Kuwana

given: Masataka

family: Makino

full_name: Shigeki Makino

given: Shigeki

family: Nishioka

full_name: Yasuhiko Nishioka

given: Yasuhiko

family: Ogura

full_name: Takashi Ogura

given: Takashi

family: Takizawa

full_name: Ayako Takizawa

given: Ayako

family: Ugai

full_name: Hiroyuki Ugai

given: Hiroyuki

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

family: Schlenker-Herceg

full_name: Rozsa Schlenker-Herceg

given: Rozsa

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

journal_name: Respiratory Medicine

title: Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial

ReferenceCitation: Cottin V, Richeldi L, Rosas I, Otaola M, Song JW, Tomassetti S, Wijsenbeek M, Schmitz M, Coeck C, Stowasser S, Schlenker-Herceg R, Kolb M; INBUILD Trial Investigators. Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Respir Res. 2021 Mar 16;22(1):84. doi: 10.1186/s12931-021-01668-1.

family: Cottin

full_name: Vincent Cottin

given: Vincent

family: Richeldi

full_name: Luca Richeldi

given: Luca

family: Rosas

full_name: Ivan Rosas

given: Ivan

family: Otaola

full_name: Maria Otaola

given: Maria

family: Song

full_name: Jin Woo Song

given: Jin Woo

family: Tomassetti

full_name: Sara Tomassetti

given: Sara

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6). pii: 2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Wells AU, Flaherty KR, Brown KK, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts WA, Stowasser S, Quaresma M, Goeldner RG, Schlenker-Herceg R, Kolb M; INBUILD trial investigators. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020 May;8(5):453-460. doi: 10.1016/S2213-2600(20)30036-9. Epub 2020 Mar 5.

repositories_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

title: Nintedanib in patients with progressive fibrosing interstitial lung diseases—subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial

ReferenceCitation: Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.

name: From the Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor (K.R.F.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust (A.U.W.), the National Heart and Lung Institute, Imperial College (A.U.W., A.D., S.L.F.W.), and the Department of Radiology, Royal Brompton and Harefield NHS Foundation Trust (A.D.) — all in London; the National Reference Center for Rare Pulmonary Diseases, Louis Pradel...

ReferenceCitation: Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg R. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017.

location_country:
Italy
United States
Chile
Spain
Germany
France
Japan
Poland
Belgium
Argentina
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

location_facility: The First Hospital of Chinese Medical University

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: University of Florida College of Medicine

location_facility: Scientific Research Institute of Pulmonology

location_facility: Pulmonology Scientific Research Institute

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: The Ohio State University Wexner Medical Center

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: University of Minnesota Masonic Cancer Center

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: University of Maryland School of Medicine

location_facility: University of Utah Health Sciences Center

location_facility: Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: The Catholic University of Korea, Bucheon St.Mary's Hospital

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: Kobe City Medical Center General Hospital

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: University of Texas Southwestern Medical Center

title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

summary: The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.


ReferenceType: derived

ReferenceCitation: Siu LL, Even C, Mesía R, Remenar E, Daste A, Delord JP, Krauss J, Saba NF, Nabell L, Ready NE, Braña I, Kotecki N, Zandberg DP, Gilbert J, Mehanna H, Bonomi M, Jarkowski A, Melillo G, Armstrong JM, Wildsmith S, Fayette J. Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):195-203. doi: 10.1001/jamaoncol.2018.4628.

name: Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada

family: Siu

full_name: Lillian L. Siu

given: Lillian L.

sequence: first

name: Department of Head and Neck Cancer, Gustave Roussy, Villejuif, France

family: Even

full_name: Caroline Even

given: Caroline

sequence: additional

name: Medical Oncology Department, Catalan Institute of Oncology–Badalona, University of Barcelona, IDIBELL, Barcelona, Spain

family: Mesía

full_name: Ricard Mesía

given: Ricard

name: Fej-nyak Állcsont, Rekonstrukciós Plasztikai Sebészeti és Laser Sebészeti Osztály, Országos Onkológiai Intézet, Budapest, Hungary

family: Remenar

full_name: Eva Remenar

given: Eva

name: Department of Medical Oncology, Hôpital Saint André, Bordeaux, France

family: Daste

full_name: Amaury Daste

given: Amaury

name: Département d’Oncologie Médicale, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, France

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

name: Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany

family: Krauss

full_name: Jürgen Krauss

given: Jürgen

name: Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia

family: Saba

full_name: Nabil F. Saba

given: Nabil F.

name: Department of Medical Oncology, University of Alabama at Birmingham, Comprehensive Cancer Center, Birmingham

family: Nabell

full_name: Lisle Nabell

given: Lisle

name: Department of Medicine, Duke University Medical Center, Durham, North Carolina

family: Ready

full_name: Neal E. Ready

given: Neal E.

name: Medical Oncology Department, Vall d’Hebron University Hospital, Universitat Autonoma de Barcelona, Spain

family: Braña

full_name: Irene Braña

given: Irene

name: Département de Cancérologie Cervico-Faciale, Centre de Lutte Contre le Cancer–Centre Oscar Lambret, Lille, France

family: Kotecki

full_name: Nuria Kotecki

given: Nuria

name: University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, Pennsylvania

family: Zandberg

full_name: Dan P. Zandberg

given: Dan P.

name: Department of Hematology and Oncology, Henry-Joyce Cancer Clinic, Nashville, Tennessee

family: Gilbert

full_name: Jill Gilbert

given: Jill

name: Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Birmingham, United Kingdom

family: Mehanna

full_name: Hisham Mehanna

given: Hisham

name: Department of Medical Oncology, The Ohio State University, Columbus, Ohio

family: Bonomi

full_name: Marcelo Bonomi

given: Marcelo

name: Now with Bristol-Myers Squibb, New Brunswick, New Jersey

family: Jarkowski

full_name: Anthony Jarkowski

given: Anthony

family: Melillo

full_name: Giovanni Melillo

given: Giovanni

family: Armstrong

full_name: Jon M. Armstrong

given: Jon M.

name: Precision Medicine and Genomics, IMED Biotech Unit, AstraZeneca, Cambridge, United Kingdom

family: Wildsmith

full_name: Sophie Wildsmith

given: Sophie

name: Clinical Oncology, Cancer Center Centre Léon Bérard, University of Lyon, Lyon, France

family: Fayette

full_name: Jérôme Fayette

given: Jérôme

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA Oncology

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

version: publishedVersion

license_normalized: no license

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
diposit.ub.edu

title: Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1–Low/Negative Recurrent or Metastatic HNSCC

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

location_country:
United States
Germany
France
Czechia
Malaysia
Israel
Georgia
Hungary
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

title: A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.


type: EudraCT Number

title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

acronym: NAVIGATE ESUS

summary: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Hart RG, Sharma M, Mundl H, Kasner SE, Bangdiwala SI, Berkowitz SD, Swaminathan B, Lavados P, Wang Y, Wang Y, Davalos A, Shamalov N, Mikulik R, Cunha L, Lindgren A, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi RJ, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni D, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, Endres M, Muir KW, Bornstein N, Ozturk S, O'Donnell MJ, De Vries Basson MM, Pare G, Pater C, Kirsch B, Sheridan P, Peters G, Weitz JI, Peacock WF, Shoamanesh A, Benavente OR, Joyner C, Themeles E, Connolly SJ; NAVIGATE ESUS Investigators. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med. 2018 Jun 7;378(23):2191-2201. doi: 10.1056/NEJMoa1802686. Epub 2018 May 16.

name: From the Departments of Medicine–Neurology (R.G.H., M.S., A.S.), Health Research Methods, Evidence, and Impact (S.I.B.), Pathology and Molecular Medicine (G. Pare), and Medicine–Cardiology (S.J.C.), Population Health Research Institute (B.S., P.S., E.T.), and the Thrombosis and Atherosclerosis Research Institute and McMaster University (J.I.W.), Hamilton, ON, the Vancouver Stroke Program, University of British Columbia, Vancouver (O.R.B.), and Sunnybrook Health Sciences Centre, University of Toronto,...

family: Hart

full_name: Robert G. Hart

given: Robert G.

family: Sharma

full_name: Mukul Sharma

given: Mukul

family: Mundl

full_name: Hardi Mundl

given: Hardi

family: Kasner

full_name: Scott E. Kasner

given: Scott E.

family: Bangdiwala

full_name: Shrikant I. Bangdiwala

given: Shrikant I.

family: Berkowitz

full_name: Scott D. Berkowitz

given: Scott D.

family: Swaminathan

full_name: Balakumar Swaminathan

given: Balakumar

family: Lavados

full_name: Pablo Lavados

given: Pablo

family: Wang

full_name: Yongjun Wang

given: Yongjun

full_name: Yilong Wang

given: Yilong

family: Davalos

full_name: Antonio Davalos

given: Antonio

family: Shamalov

full_name: Nikolay Shamalov

given: Nikolay

family: Mikulik

full_name: Robert Mikulik

given: Robert

family: Cunha

full_name: Luis Cunha

given: Luis

family: Lindgren

full_name: Arne Lindgren

given: Arne

family: Arauz

full_name: Antonio Arauz

family: Lang

full_name: Wilfried Lang

given: Wilfried

family: Czlonkowska

full_name: Anna Czlonkowska

given: Anna

family: Eckstein

full_name: Jens Eckstein

given: Jens

family: Gagliardi

full_name: Rubens J. Gagliardi

given: Rubens J.

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

family: Ameriso

full_name: Sebastian F. Ameriso

given: Sebastian F.

family: Tatlisumak

full_name: Turgut Tatlisumak

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

title: Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source

ReferenceCitation: Kasner SE, Lavados P, Sharma M, Wang Y, Wang Y, Dávalos A, Shamalov N, Cunha L, Lindgren A, Mikulik R, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi R, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni DS, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, DeVries Basson MM, Endres M, Muir K, Bornstein N, Ozturk S, O'Donnell M, Mundl H, Pater C, Weitz J, Peacock WF, Swaminathan B, Kirsch B, Berkowitz SD, Peters G, Pare G, Themeles E, Shoamanesh A, Connolly SJ, Hart RG; NAVIGATE ESUS Steering Committee and Investigators. Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial. J Stroke Cerebrovasc Dis. 2018 Jun;27(6):1673-1682. doi: 10.1016/j.jstrokecerebrovasdis.2018.01.027. Epub 2018 Mar 7.

journal_name: Journal of Stroke and Cerebrovascular Diseases

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories: HELDA - Digital Repository of the University of Helsinki

title: Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial

ReferenceCitation: Hart RG, Sharma M, Mundl H, Shoamanesh A, Kasner SE, Berkowitz SD, Pare G, Kirsch B, Pogue J, Pater C, Peters G, Davalos A, Lang W, Wang Y, Wang Y, Cunha L, Eckstein J, Tatlisumak T, Shamalov N, Mikulik R, Lavados P, Hankey GJ, Czlonkowska A, Toni D, Ameriso SF, Gagliardi RJ, Amarenco P, Bereczki D, Uchiyama S, Lindgren A, Endres M, Brouns R, Yoon BW, Ntaios G, Veltkamp R, Muir KW, Ozturk S, Arauz A, Bornstein N, Bryer A, O'Donnell MJ, Weitz J, Peacock F, Themeles E, Connolly SJ. Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. Eur Stroke J. 2016 Sep;1(3):146-154. doi: 10.1177/2396987316663049. Epub 2016 Aug 3.

name: Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada

name: Department of Neurology, University of Pennsylvania, Philadelphia, USA

name: Bayer Healthcare Pharmaceuticals, Parsippany, USA

name: Department of Clinical Epidemiology and Biostatistics, Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada

name: Janssen Research and Development, LLC, Spring House, Pennsylvania, USA

name: Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain

name: Hospital St. John of God, Medical Faculty, Sigmund Freud University, Vienna, Austria

name: Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

name: Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

name: Department of Innere Medizin, Universitätsspital Basel, Basel, Switzerland

name: Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland

name: Pirogov Russian National Research Medical University, Moscow, Russia

name: International Clinical Research Center and Neurology Department, St. Anne’s University Hospital, Brno, Czech Republic

name: Clinica Alemana de Santiago, Universidad del Desarrollo, Universidad de Chile, Santiago, Chile

name: School of Medicine and Pharmacology, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia

name: 2nd Department of Neurology, Institute of Psychiatry and Neurology, Medical University of Warsaw, Warsaw, Poland

name: Department of Neurology and Psychiatry, “Sapienza” University of Rome, Rome, Italy

name: Institute for Neurological Research, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI), Buenos Aires, Argentina

name: Irmandade da Santa Casa de Misericórdia de São Paulo, Sao Paulo, Brazil

name: Department of Neurology, Bichat Hospital, Paris, France

name: Department of Neurology, Semmelweis University, Budapest, Hungary

name: Sanno Hospital and Sanno Medical Center, Tokyo, Japan

name: Department of Clinical Sciences (Neurology), Department of Neurology and Rehabilitation Medicine, Skane University Hospital, Lund University, Lund, Sweden

name: Klinik und Hochschulambulanz für Neurologie, Center for Stroke Research Berlin, Charité-Universitätsmedizin, Berlin, Germany

name: Universitair Ziekenhuis Brussel, Brussels, Belgium

name: Department of Neurology, Seoul National University Hospital, Seoul, Korea

name: Department of Medicine, University of Thessaly, Larissa, Greece

name: Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK

name: Department of Neurology, Selcuk University, Konya, Turkey

name: Instituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico

name: Tel-Aviv Medical Center, Tel-Aviv, Israel

name: Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa

name: National University of Ireland, Galway, Ireland

name: Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Canada

name: Baylor College of Medicine, Houston, USA

name: Population Health Research Institute, Hamilton, Canada

name: Department of Medicine (Cardiology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada

ReferenceCitation: Sharma M, Smith EE, Pearce LA, Perera KS, Kasner SE, Yoon BW, Ameriso SF, Puig J, Damgaard D, Fiebach JB, Muir KW, Veltkamp RC, Veltkamp RC, Toni DS, Shamalov N, Gagliardi RJ, Mikulik R, Engelter ST, Bereczki D, O'Donnell MJ, Saad F, Shoamanesh A, Berkowitz SD, Mundl H, Hart RG; NAVIGATE ESUS MRI Substudy Investigators. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. Int J Stroke. 2021 Nov 18:17474930211058012. doi: 10.1177/17474930211058012. [Epub ahead of print]

name: Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada

name: Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada

name: Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA

name: Division de Neurologia Vascular, Departmento de Neurologia, Institute for Neurological Research-FLENI, Cuidad Autonoma, Buenos Aires, Argentina

name: Department of Radiology, Girona Biomedical Research Institute, Hospital Dr. Josep Trueta, Girona, Spain

name: Department of Neurology, Aarhus University Hospital, Aarhus, Denmark

name: Center for Stroke Research, Charite – Universitatsmedizin Berlin, Berlin, Germany

name: Institute of Neuroscience & Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK

name: Department of Brain Sciences, Imperial College London, London, UK

name: Department of Human Neurosciences, “Sapienza” University of Rome, Rome, Italy

name: Federal Center of Brain Research and Neurotechnology, Federal Medical Biological Agency, Moscow, Russia

name: International Clinical Research Center and Neurology Department, St. Anne’s University Hospital and Masaryk University, Brno, Czech Republic

name: University Department of Geriatic Medicine Felix Platter, Department of Neurology, University of Basel, University Hospital Basel, Basel, Switzerland

name: HRB-Clinical Research Facility, National University Ireland, Galway, Ireland

name: Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ, USA

name: Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada

name: On behalf of the NAVIGATE ESUS MRI Substudy Investigators

ReferenceCitation: Merkler AE, Pearce LA, Kasner SE, Shoamanesh A, Birnbaum LA, Kamel H, Sheth KN, Sharma R. Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Oct 25. doi: 10.1001/jamaneurol.2021.3828. [Epub ahead of print]

name: Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York

name: Department of Neurology, Weill Cornell Medical College, New York, New York

name: Biostatistics Consultant, St Catharines, Ontario, Canada

name: Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia

name: Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton, Canada

name: Department of Neurosurgery, University of Texas Health Sciences Center, San Antonio

name: Department of Neurology, Yale University School of Medicine, New Haven, Connecticut

ReferenceCitation: Sharma M, Smith EE, Pearce LA, Shoamanesh A, Perera KS, Coutts SB, Damgaard D, Ameriso SF, Rha JH, Modrau B, Yoon BW, Romano M, Messé SR, Barlinn J, Lambeck J, Saad F, Berkowitz SD, Mundl H, Connolly SJ, Hart RG; NAVIGATE ESUS MIND MRI Substudy Investigators. Frequency and Patterns of Brain Infarction in Patients With Embolic Stroke of Undetermined Source: NAVIGATE ESUS Trial. Stroke. 2021 Sep 20:STROKEAHA120032976. doi: 10.1161/STROKEAHA.120.032976. [Epub ahead of print]

name: Department of Medicine (Neurology), McMaster University/Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada (M.S, A.S., K.S.P.).

name: Department of Clinical Neurosciences, University of Calgary, Alberta, Canada (E.E.S.).

name: Biostatistics Consultant, St. Catharines, Ontario, Canada (L.A.P.)

name: Department of Clinical Neurosciences, Radiology, and Community Health Sciences, University of Calgary, Alberta, Canada. (S.B.C.)

name: Department of Neurology, Aarhus University Hospital, Denmark (D.D.).

name: Institute for Neurological Research-FLENI, Buenos Aires, Argentina (S.F.A.).

name: Inha University Hospital, Incheon, Korea (J.-H.R.).

name: Department of Neurology, Aalborg University Hospital, Denmark (B.M.).

name: Department of Neurology, Seoul National University Hospital, Korea (B.-W.Y.).

name: Department of Neurology, Centro Estudios Medicos e Invest. Clinicas “Dr. N. Quirno”, Buenos Aires, Argentina (M.R.).

name: Department of Neurology, University of Pennsylvania, Philadelphia (S.R.M.).

name: Department of Neurology, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany (J.B.).

name: Department of Neurology and Clinical Neurophysiology, Universitätsklinikum Freiburg, Germany (J.L.).

name: Department of Clinical Neurosciences, University of Calgary, Alberta, Canada. (F.S.)

name: Population Health Research Institute, Hamilton Health Sciences, Ontario, Canada (R.G.H., S.J.C.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Shoamanesh A, Hart RG, Connolly SJ, Kasner SE, Smith EE, Martí-Fàbregas J, Liu YY, Uchiyama S, Mikulik R, Veltkamp R, O'Donnell MJ, Ntaios G, Muir KW, Field TS, Santo GC, Olavarria V, Mundl H, Lutsep H, Berkowitz SD, Sharma M. Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Jan 1;78(1):11-20. doi: 10.1001/jamaneurol.2020.3836. Erratum in: JAMA Neurol. 2021 Jan 1;78(1):120.

name: Division of Neurology, McMaster University / Population Health Research Institute, Hamilton, Ontario, Canada

name: Department of Neurology, University of Pennsylvania, Philadelphia

name: Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada

name: Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

name: Department of Statistics, Population Health Research Institute, Hamilton, Ontario, Canada

name: Department of Neurology, Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan

name: International Clinical Research Center and Department of Neurology, St. Anne’s University Hospital and Masaryk University, Brno, Czech Republic

name: Department of Neurology, Imperial College Healthcare NHS Trust, London, United Kingdom

name: Department of Medicine, National University of Ireland Galway, Galway, Ireland

name: Department of Internal Medicine, University of Thessaly, Larissa, Greece

name: Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, Scotland

name: Division of Neurology, University of British Columbia, Vancouver, Canada

name: Department of Neurology, Hospitais da Universidade de Coimbra, Coimbra, Portugal

name: Department of Neurology and Psychiatry, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo, Santiago, Chile

name: Pharmaceuticals Development, TA Cardiovascular, Bayer Pharma AG, Wuppertal, Germany

name: Department of Neurology, Oregon Health and Science University, Portland

name: Thrombosis Group, Pharmaceuticals Research and Development, Bayer, Whippany, New Jersey

title: Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source

ReferenceCitation: Scheitz JF, Pare G, Pearce LA, Mundl H, Peacock WF, Czlonkowska A, Sharma M, Nolte CH, Shoamanesh A, Berkowitz SD, Krahn T, Endres M; NAVIGATE-ESUS Biomarker Working Group. High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source. Stroke. 2020 Aug;51(8):2386-2394. doi: 10.1161/STROKEAHA.120.029628. Epub 2020 Jul 9.

name: Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).

name: Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin, Germany (J.F.S., C.H.N., M.E.).

name: DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany (J.F.S., C.H.N., M.E.).

name: Berlin Institute of Health (BIH), Germany (J.F.S., C.H.N., M.E.).

name: Population Health Research Institute, McMaster University, Hamilton, ON, Canada (G.P.).

name: Biostatistics Consultant, Minot, ND (L.A.P.).

name: Bayer AG, Wuppertal, Germany (H.M., T.K.).

name: Baylor College of Medicine, Houston, TX (W.F.P.).

name: 2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland (A.C.).

name: Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Canada (M.S., A.S.).

name: Research & Development, Pharmaceuticals, Bayer U.S., LLC, Whippany (S.D.B.).

name: Department of Pharmacology and Personalised Medicine, Maastricht University, the Netherlands (T.K.).

name: DZNE (German Center for Neurodegenerative Disease), partner site Berlin, Germany (M.E.).

name: on behalf of the NAVIGATE-ESUS Biomarker Working Group

ReferenceCitation: Veltkamp R, Pearce LA, Korompoki E, Sharma M, Kasner SE, Toni D, Ameriso SF, Mundl H, Tatlisumak T, Hankey GJ, Lindgren A, Berkowitz SD, Arauz A, Ozturk S, Muir KW, Chamorro Á, Perera K, Shuaib A, Rudilosso S, Shoamanesh A, Connolly SJ, Hart RG. Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Oct 1;77(10):1233-1240. doi: 10.1001/jamaneurol.2020.1995. Erratum in: JAMA Neurol. 2020 Oct 1;77(10):1322.

name: Division of Brain Sciences, Imperial College London, London, United Kingdom

name: Department of Neurology, Alfried Krupp Krankenhaus, Essen, Germany

name: currently a biostatistics consultant, St Catharines, Ontario, Canada

name: Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece

name: Population Health Research Institute, Department of Medicine, McMaster University, Hamilton, Ontario, Canada

name: Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy

name: Departamento de Neurología, Fleni, Buenos Aires, Argentina

name: Department of Clinical Neuroscience, Institute of Neurosciences and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden

name: Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden

name: Faculty of Health and Medical Sciences, Medical School, University of Western Australia, Perth, Australia

name: Department of Clinical Sciences and Neurology, Lund University, Lund, Sweden

name: Department of Neurology, Skåne University Hospital, Lund, Sweden

name: Instituto Nacional de Neurologia y Neurocirugia Manual Velasco Suarez, Mexico City, Mexico

name: Department of Neurology, Faculty of Medicine, Selcuk University, Konya, Turkey

name: Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom

name: Department of Neuroscience, Hospital Clinic of Barcelona, Institute Reçerca Biomèdica August Pi i Sunyer, University of Barcelona, Barcelona, Spain

name: Department of Medicine, University of Alberta, Edmonton, Canada

repository_institution: University of Western Australia - UWA Profiles and Research Repository

repositories:
PubMed Central
Pure (Denmark)
iris.uniroma1.it

repositories_institution: University of Western Australia - UWA Profiles and Research Repository

title: Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source

ReferenceCitation: Mikulík R, Eckstein J, Pearce LA, Mundl H, Rudilosso S, Olavarría VV, Shoamanesh A, Chamorro Á, Martí-Fàbregas J, Veltkamp R, Öztürk Ş, Tatlisumak T, Peacock WF, Berkowitz SD, Connolly SJ, Hart RG. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial. Stroke. 2020 Jul;51(7):2139-2147. doi: 10.1161/STROKEAHA.119.027995. Epub 2020 Jun 10.

name: International Clinical Research Center and Neurology Department, St. Anne’s University Hospital and Masaryk University Brno, Czech Republic (R.M.).

name: Department of Internal Medicine, University Hospital Basel, Switzerland (J.E.).

name: Comprehensive Stroke Center, Department of Neuroscience (S.R.), Hospital Clinic, Barcelona, Spain.

name: Department of Neurology and Psychiatry, Faculty of Medicine, Universidad del Desarrollo, Clínica Alemana de Santiago, Santiago, Chile (V.V.O.).

name: McMaster University/Population Health Research Institute, Hamilton Health Sciences, ON, Canada (A.S., S.J.C., R.G.H.).

name: Comprehensive Stroke Center, Department of Neuroscience (A.C.), Hospital Clinic, Barcelona, Spain.

name: Hospital de La Santa Creu Isant Pau, Barcelona, Spain (J.M.-F.).

name: Imperial College London, United Kingdom (R.V.).

name: Department of Neurology, Selcuk University Faculty of Medicine, Turkey (S.O.).

name: Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden (T.T.).

name: Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden (T.T.).

name: Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ (S.D.B.).

title: Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source

ReferenceCitation: Ntaios G, Pearce LA, Veltkamp R, Sharma M, Kasner SE, Korompoki E, Milionis H, Mundl H, Berkowitz SD, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial. Stroke. 2020 Jun;51(6):1797-1804. doi: 10.1161/STROKEAHA.119.028669. Epub 2020 Apr 16.

name: From the Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece (G.N.)

name: Biostatistics Consultant, Minot, ND (L.A.P.)

name: Imperial College London, United Kingdom (R.V., E.K.)

name: Department of Neurology, Alfried-Krupp Krankenhaus, Essen, Germany (R.V.)

name: Population Health Research Institute, Hamilton Health Sciences, ON, Canada (M.S., R.G.H.)

name: Department of Neurology, University of Pennsylvania, Philadelphia (S.E.K.)

name: Department of Clinical Therapeutics, Alexandra Hospital, University of Athens, Greece (E.K.)

name: Department of Internal Medicine, University of Ioannina, Greece (H.M.)

name: Bayer US LLC, Pharmaceuticals Clinical Development Thrombosis, NJ (S.D.B.)

name: Department of Medicine (Cardiology), McMaster University/Population Health Research Institute, Hamilton, ON, Canada (S.J.C.).

name: on behalf of the NAVIGATE ESUS Investigators

title: Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial

ReferenceCitation: Martinez-Majander N, Ntaios G, Liu YY, Ylikotila P, Joensuu H, Saarinen J, Perera KS, Marti-Fabregas J, Chamorro A, Rudilosso S, Prats-Sanchez L, Berkowitz SD, Mundl H, Themeles E, Tiainen M, Demchuk A, Kasner SE, Hart RG, Tatlisumak T; NAVIGATE ESUS investigators. Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial. Eur J Neurol. 2020 May;27(5):841-848. doi: 10.1111/ene.14172. Epub 2020 Mar 11.

name: Department of Neurology Helsinki University Central Hospital Helsinki Finland

name: Department of Internal Medicine University of Thessaly Larissa Greece

name: Population Health Research Institute McMaster University Hamilton ON Canada

name: Division of Clinical Neurosciences Turku University Hospital Turku Finland

name: Department of Oncology Helsinki University Hospital Helsinki Finland

name: Department of Neurology Vaasa Central Hospital Vaasa Finland

name: Department of Neurology Hospital de la Santa Creu i Sant Pau Biomedical Research Institute IIB‐Sant Pau Barcelona Spain

name: Department of Neuroscience Comprehensive Stroke Center Hospital Clinic University of Barcelona  Spain

name: Calgary Stroke Program Departments of Clinical Neuroscience and Radiology and Hotchkiss Brain Institute University of Calgary Calgary AB Canada

name: Department of Neurology University of Pennsylvania Philadelphia PA USA

name: Department of Neurology Sahlgrenska University Hospital Gothenburg Sweden

name: Department of Clinical Neuroscience Institute of Neuroscience and Physiology Sahlgrenska Academy at University of Gothenburg Gothenburg Sweden

ReferenceCitation: Ntaios G, Pearce LA, Meseguer E, Endres M, Amarenco P, Ozturk S, Lang W, Bornstein NM, Molina CA, Pagola J, Mundl H, Berkowitz SD, Liu YY, Sen S, Connolly SJ, Hart RG. Aortic Arch Atherosclerosis in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Trial. Stroke. 2019 Nov;50(11):3184-3190. doi: 10.1161/STROKEAHA.119.025813. Epub 2019 Sep 17.

name: From the Department of Internal Medicine, University of Thessaly, Larissa, Greece (G.N.)

name: Neurology Service, Bichat Hospital, Paris, France (E.M.)

name: Department of Neurology, Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany (M.E.)

name: German Center for Cardiovascular Research and Neurodegenerative Diseases, Partner Site Berlin (M.E.)

name: APHP, Bichat Hospital, Paris-Diderot, Sorbonne Paris Cité university, France (P.A.)

name: Department of Neurology, Selcuk University Faculty of Medicine, Konya, Turkey (S.O.)

name: Medical Faculty and Hospital St. John of God, Sigmund Freud University, Vienna, Austria (W.L.)

name: Shaare Zeek Medical Center, Jerusalem, Israel (N.M.B.)

name: Stroke Unit, Hospital Universitari Vall d´Hebron, Barcelona, Spain (C.A.M., J.P.)

name: Bayer AG, Clinical Development, Wuppertal, Germany (H.M.)

name: Bayer U.S., LLC, Whippany, NJ (S.D.B., Y.Y.L.)

name: Population Health Research Institute, Hamilton, Ontario, Canada (S.D.B., Y.Y.L.)

name: University of South Carolina, Columbia (S.S.)

name: Department of Medicine—Cardiology (S.J.C.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.

name: Department of Medicine—Neurology (R.G.H.), McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.

title: Aortic Arch Atherosclerosis in Patients With Embolic Stroke of Undetermined Source

ReferenceCitation: Ntaios G, Swaminathan B, Berkowitz SD, Gagliardi RJ, Lang W, Siegler JE, Lavados P, Mundl H, Bornstein N, Meseguer E, Amarenco P, Cucchiara B, Camps-Renom P, Makaritsis K, Korompoki E, Papavasileiou V, Marti-Fabregas J, Milionis H, Vemmos K, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Efficacy and Safety of Rivaroxaban Versus Aspirin in Embolic Stroke of Undetermined Source and Carotid Atherosclerosis. Stroke. 2019 Sep;50(9):2477-2485. doi: 10.1161/STROKEAHA.119.025168. Epub 2019 Aug 12.

name: From the Department of Internal Medicine, University of Thessaly, Larissa, Greece (G.N., K.M.)

name: Population Health Research Institute, Hamilton, ON, Canada (B.S.)

name: Irmandade da Santa Casa de Misericórdia de São Paulo, Brazil (R.J.G.)

name: Hospital St John of God, Sigmund Freud Private University, Medical Faculty, Vienna, Austria (W.L.)

name: Department of Neurology, Hospital of the University of Pennsylvania (J.E.S., B.C.)

name: Clínica Alemana de Santiago, Santiago, Chile (P.L.)

name: Shaare-Zedek Medical Center Jerusalem, Israel (N.B.)

name: APHP, Bichat hospital, Paris-Diderot, Sorbonne Paris Cité university, France (P.A.)

name: Unitat de Malalties Vasculars Cerebrals, Servei de Neurologia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (P.C.-R., J.M.-R.)

name: Division of Brain Science, Imperial College London, Charing Cross Hospital, United Kingdom (E.K.)

name: Department of Clinical Therapeutics, University Athens School of Medicine, Greece (E.K.)

name: Stroke Medicine, Leeds Teaching Hospitals NHS Trust, School of Medicine, University of Leeds, West Yorkshire, United Kingdom (V.P.)

name: School of Health Sciences, Faculty of Medicine University of Ioannina, Greece (H.M.)

name: Hellenic Cardiovascular Research Society, Athens, Greece (K.V.)

name: Department of Medicine, (Cardiology) Population Health Research Institute, McMaster University, Hamilton, ON, Canada. (S.J.C.)

name: Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton, ON, Canada. (R.G.H.)

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Switzerland
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


title: Non-Interventional Study on the Tolerability and Efficacy of IVIG

summary: Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

status: Completed

study_type: Observational

time_perspective: Prospective

lead_sponsor: Octapharma

location_country:
Austria
France
Spain
Canada
United Kingdom

location_facility:
Hamilton Health Sciences
Hospital for Sick Children
Octapharma Research Center
St. Michael's Hospital
Health Sciences Centre
St. Paul's Hospital
Octapharma Research Site
Octapharma Research Location

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

summary: The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other standard treatment option, nor did they qualify for another clinical study for PV

primary_purpose: Treatment

lead_sponsor: Novartis Pharmaceuticals

location_country: Austria Chile Sweden Mexico Germany France Bulgaria Thailand Norway Belgium Portugal Canada

intervention_type: Drug


ReferenceCitation: Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1.

family: Highland

full_name: Kristin B Highland

given: Kristin B

family: Distler

full_name: Oliver Distler

given: Oliver

family: Kuwana

full_name: Masataka Kuwana

given: Masataka

family: Allanore

full_name: Yannick Allanore

given: Yannick

family: Assassi

full_name: Shervin Assassi

given: Shervin

family: Azuma

full_name: Arata Azuma

given: Arata

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Denton

full_name: Christopher P Denton

given: Christopher P

full_name: Jörg H W Distler

given: Jörg H W

family: Hoffmann-Vold

full_name: Anna Maria Hoffmann-Vold

given: Anna Maria

family: Khanna

full_name: Dinesh Khanna

given: Dinesh

family: Mayes

full_name: Maureen D Mayes

given: Maureen D

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

family: Vonk

full_name: Madelon C Vonk

given: Madelon C

family: Gahlemann

full_name: Martina Gahlemann

given: Martina

family: Clerisme-Beaty

full_name: Emmanuelle Clerisme-Beaty

given: Emmanuelle

family: Girard

full_name: Mannaig Girard

given: Mannaig

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

family: Zoz

full_name: Donald Zoz

given: Donald

family: Maher

full_name: Toby M Maher

given: Toby M

journal_name: The Lancet Respiratory Medicine

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Roennow A, Sauvé M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houÿez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473.

family: Roennow

full_name: Annelise Roennow

given: Annelise

ReferenceCitation: Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19.

ReferenceCitation: Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8.

name: National Heart and Lung Institute Imperial College London and NIHR Clinical Research Facility Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California  Los Angeles

name: University of Texas McGovern Medical School  Houston

name: Thoraxklinik University of Heidelberg, and the German Center for Lung Research  Heidelberg Germany

name: University of California  David Geffen School of Medicine, Los Angeles

name: University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden  Dresden Germany

name: Hospital de la Santa Creu i Sant Pau  Barcelona Spain

name: University of Genova IRCCS San Martino Polyclinic Hospital  Genova Italy

name: Boehringer Ingelheim Pharma GmbH & Co. KG  Ingelheim am Rhein Germany

name: Boehringer Ingelheim International GmbH, Ingelheim am Rhein  Germany

title: Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis−Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double‐Blind, Placebo‐Controlled Trial

ReferenceCitation: Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23.

name: Department of Allergy and Rheumatology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan

name: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan

name: Osaka Medical College Mishima Minami Hospital, Osaka, Japan

name: Department of Advanced and Integrated Interstitial Lung Diseases Research, Toho University, Tokyo, Japan

name: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan

name: Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan

name: Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland

name: Department of Dermatology, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan

name: Department of Pulmonary, Infection and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan

ReferenceCitation: Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.

name: From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) — both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of...

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Nintedanib for Systemic Sclerosis–Associated Interstitial Lung Disease

ReferenceCitation: Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS™ trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS™). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.

location_country:
Finland
Malaysia
Greece
Australia
Belgium
Denmark
India
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Chile
Sweden
Switzerland
Netherlands
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

acronym:
Nintedanib in SSc-ILD

 Nindedanib dans la SSc-ILD

location_facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Semmelweis University, Dept. Pulmonology

location_facility: Azienda Universitaria-Universita' La Sapienza

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: The First Hospital of Chinese Medical University

location_facility: University of Florida College of Medicine

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: B.J. Medical College and Sasoon General Hospital

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Kantonspital St. Gallen, Rheumatologie Department

location_facility: EMED, Center of Medical Services,Private Prac,Rzeszow

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: University of Utah Health Sciences Center

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: National Hospital Organization Himeji Medical Center

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Postgraduate Institute of Medical Education And Research

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Klinikum der Universität München - Campus Großhadern

title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

summary: Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.


title: A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics

summary: To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.

lead_sponsor: AstraZeneca

location_country:
Italy
United States
France
Germany
United Kingdom

intervention_type: Other


title: A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

ipd_sharing: Yes

location_country:
United States
Germany
France
Czechia
Malaysia
Israel
Georgia
Hungary
Belgium
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan


type: Other Grant/Funding Number

type: Registry Identifier

title: A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC

acronym: SPLENDOUR

summary: The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called "non small cell lung cancer" (NSCLC) that has spread to other parts of the body.

ReferenceType: background

ReferenceCitation: Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004 Jun 15;100(12):2613-21.

ReferenceCitation: Tsuya A, Kurata T, Tamura K, Fukuoka M. Skeletal metastases in non-small cell lung cancer: a retrospective study. Lung Cancer. 2007 Aug;57(2):229-32. Epub 2007 Apr 23.

ReferenceCitation: Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol. 2011 Mar 20;29(9):1125-32. doi: 10.1200/JCO.2010.31.3304. Epub 2011 Feb 22.

ReferenceCitation: Tan W, Zhang W, Strasner A, Grivennikov S, Cheng JQ, Hoffman RM, Karin M. Tumour-infiltrating regulatory T cells stimulate mammary cancer metastasis through RANKL-RANK signalling. Nature. 2011 Feb 24;470(7335):548-53. doi: 10.1038/nature09707. Epub 2011 Feb 16.

ReferenceCitation: Scagliotti GV, Hirsh V, Siena S, Henry DH, Woll PJ, Manegold C, Solal-Celigny P, Rodriguez G, Krzakowski M, Mehta ND, Lipton L, García-Sáenz JA, Pereira JR, Prabhash K, Ciuleanu TE, Kanarev V, Wang H, Balakumaran A, Jacobs I. Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study. J Thorac Oncol. 2012 Dec;7(12):1823-1829. doi: 10.1097/JTO.0b013e31826aec2b.

ipd_sharing: No

lead_sponsor: European Thoracic Oncology Platform

location_country:
Italy
Austria
Switzerland
United Kingdom
France
Poland
Ireland
Belgium
Spain
Germany
Slovenia

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: ASKLEPIOS - Fachkliniken München - Gauting

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Assistance Publique-Hôitaux de Marseille

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: Hôpitale de la Cavale Blanche - CHRU de BREST

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre hospitalier universitaire d'Angers


type: Other Identifier

title: A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

summary: The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Finland
Australia
Belgium
Denmark
France
Poland
Canada
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Unita Operativa Trapianto di Fegato e Multiorgano

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

location_facility: Univ. Klinik und Poliklinik fuer Urologie

location_facility: Unita Operativa Complessa di Chirurgia dei Trapianti

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: University of Stellenbosch, Tygerberg Hospital

location_facility: Instituto Mexicano de Transplantes Cuernava

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Azienda Ospedaliera Ospedale Maggiore di Milano

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Policlinico Universitario Agostino Gemelli


title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

acronym: STAR Extension

summary: To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

design_allocation: Non-Randomized

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
Romania
Belgium
Denmark
Taiwan
Ukraine
Croatia
France
Lithuania
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Estonia


title: A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

acronym: ENSURE-AF

summary: The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

ReferenceCitation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

family: Giugliano

full_name: Robert P. Giugliano

given: Robert P.

family: Ruff

full_name: Christian T. Ruff

given: Christian T.

family: Braunwald

full_name: Eugene Braunwald

given: Eugene

family: Murphy

full_name: Sabina A. Murphy

given: Sabina A.

family: Wiviott

full_name: Stephen D. Wiviott

given: Stephen D.

family: Halperin

full_name: Jonathan L. Halperin

given: Jonathan L.

family: Waldo

full_name: Albert L. Waldo

given: Albert L.

family: Ezekowitz

full_name: Michael D. Ezekowitz

given: Michael D.

family: Weitz

full_name: Jeffrey I. Weitz

given: Jeffrey I.

family: Špinar

full_name: Jindřich Špinar

given: Jindřich

family: Ruzyllo

full_name: Witold Ruzyllo

given: Witold

family: Ruda

full_name: Mikhail Ruda

given: Mikhail

family: Koretsune

full_name: Yukihiro Koretsune

given: Yukihiro

family: Betcher

full_name: Joshua Betcher

given: Joshua

family: Shi

full_name: Minggao Shi

given: Minggao

family: Grip

full_name: Laura T. Grip

given: Laura T.

family: Patel

full_name: Shirali P. Patel

given: Shirali P.

full_name: Indravadan Patel

given: Indravadan

family: Hanyok

full_name: James J. Hanyok

given: James J.

family: Mercuri

full_name: Michele Mercuri

given: Michele

family: Antman

full_name: Elliott M. Antman

given: Elliott M.

journal_name: New England Journal of Medicine

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

title: Edoxaban versus Warfarin in Patients with Atrial Fibrillation

ReferenceCitation: Goette A, Kwong WJ, Ezekowitz MD, Banach M, Hjortshoj SP, Zamoryakhin D, Lip GYH. Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study. Europace. 2018 Dec 1;20(12):1936-1943. doi: 10.1093/europace/euy141.

name: St. Vincenz-Hospital Paderborn, Am Busdorf 2, Paderborn, Germany

name: Working Group: Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany

name: Daiichi Sankyo, Inc., Basking Ridge, NJ, USA

name: Sidney Kimmel Jefferson Medical College at Thomas Jefferson University and Lankenau Medical Center, Broomall, PA, USA

name: Medical University of Lodz, Lodz, Poland

name: Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark

name: Daiichi Sankyo Development, Ltd, Gerrards Cross, UK

name: Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK

name: Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

repository_institution: Aalborg Universitet - VBN Forskningsportal

ReferenceCitation: Goette A, Merino JL, Ezekowitz MD, Zamoryakhin D, Melino M, Jin J, Mercuri MF, Grosso MA, Fernandez V, Al-Saady N, Pelekh N, Merkely B, Zenin S, Kushnir M, Spinar J, Batushkin V, de Groot JR, Lip GY; ENSURE-AF investigators. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016 Oct 22;388(10055):1995-2003. doi: 10.1016/S0140-6736(16)31474-X. Epub 2016 Aug 30. Erratum in: Lancet. 2016 Oct 22;388(10055):1984.

title: Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial

ReferenceCitation: Lip GY, Merino J, Ezekowitz M, Ellenbogen K, Zamoryakhin D, Lanz H, Jin J, Al-Saadi N, Mercuri M, Goette A. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart J. 2015 May;169(5):597-604.e5. doi: 10.1016/j.ahj.2015.02.009. Epub 2015 Feb 21.

repositories_institution: University of Birmingham - University of Birmingham Research Portal

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Czechia
Bulgaria
Israel
Poland
Romania
Hungary
Belgium
Russian Federation
Spain
Denmark
United States
United Kingdom
Ukraine

location_facility:
Second site in
Third site in
First site in
Bad Friedrichshall


ReferenceCitation: Steg PG, Bhatt DL, Simon T, Fox K, Mehta SR, Harrington RA, Held C, Andersson M, Himmelmann A, Ridderstråle W, Leonsson-Zachrisson M, Liu Y, Opolski G, Zateyshchikov D, Ge J, Nicolau JC, Corbalán R, Cornel JH, Widimský P, Leiter LA; THEMIS Steering Committee and Investigators. Ticagrelor in Patients with Stable Coronary Disease and Diabetes. N Engl J Med. 2019 Oct 3;381(14):1309-1320. doi: 10.1056/NEJMoa1908077. Epub 2019 Sep 1.

ReferenceCitation: Bhatt DL, Steg PG, Mehta SR, Leiter LA, Simon T, Fox K, Held C, Andersson M, Himmelmann A, Ridderstråle W, Chen J, Song Y, Diaz R, Goto S, James SK, Ray KK, Parkhomenko AN, Kosiborod MN, McGuire DK, Harrington RA; THEMIS Steering Committee and Investigators. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. Lancet. 2019 Sep 28;394(10204):1169-1180. doi: 10.1016/S0140-6736(19)31887-2. Epub 2019 Sep 1.

ReferenceCitation: Bhatt DL, Fox K, Harrington RA, Leiter LA, Mehta SR, Simon T, Andersson M, Himmelmann A, Ridderstråle W, Held C, Steg PG; THEMIS Steering Committee. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study. Clin Cardiol. 2019 May;42(5):498-505. doi: 10.1002/clc.23164. Epub 2019 Apr 9.

ReferenceCitation: Wittbrodt E, Bhalla N, Sundell KA, Hunt P, Wong ND, Kuster M, Mellström C. Assessment of The High risk and unmEt Need in patients with CAD and type 2 diabetes (ATHENA): US healthcare resource use, cost, and burden of illness in a commercially insured population. J Diabetes Complications. 2021 Apr;35(4):107859. doi: 10.1016/j.jdiacomp.2021.107859. Epub 2021 Jan 20.

family: Wittbrodt

full_name: Eric Wittbrodt

given: Eric

family: Bhalla

full_name: Narinder Bhalla

given: Narinder

family: Sundell

full_name: Karolina Andersson Sundell

given: Karolina Andersson

family: Hunt

full_name: Phillip Hunt

given: Phillip

family: Wong

full_name: Nathan D. Wong

given: Nathan D.

family: Kuster

full_name: Marco Kuster

given: Marco

family: Mellström

full_name: Carl Mellström

given: Carl

journal_name: Journal of Diabetes and its Complications

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10. Review.

name: Global Medicines Development, AstraZeneca Gothenburg, Pepparedsleden 1, SE-431 83 Mölndal, Sweden

family: Held

full_name: Peter Held

given: Peter

family: Himmelmann

full_name: Anders Himmelmann

given: Anders

family: Ditmarsch

full_name: Marc Ditmarsch

given: Marc

journal_name: Future Cardiology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

location_country:
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Saudi Arabia
Hong Kong
Netherlands
Philippines
Vietnam
Bulgaria
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

acronym: THEMIS

source: euctr

title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).

summary: The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.


ReferenceCitation: Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7). pii: e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23.

name: Genentech, Inc., South San Francisco, California, USA

family: Lim

full_name: Jeremy J. Lim

given: Jeremy J.

name: Department of Translational Medicine, Infectious Diseases Research Unit, Lund University, Malmö, Sweden

family: Nilsson

full_name: Anna C. Nilsson

given: Anna C.

name: London Health Sciences Centre, London, Ontario, Canada

family: Silverman

full_name: Michael Silverman

given: Michael

name: Galilee Medical Center, Department of Internal Med A, The Azrieli Faculty of Medicine, Nahariya, Israel

family: Assy

full_name: Nimer Assy

given: Nimer

family: Kulkarni

full_name: Priya Kulkarni

given: Priya

family: McBride

full_name: Jacqueline M. McBride

given: Jacqueline M.

family: Deng

full_name: Rong Deng

given: Rong

family: Li

full_name: Chloe Li

given: Chloe

family: Yang

full_name: Xiaoying Yang

given: Xiaoying

family: Nguyen

full_name: Allen Nguyen

given: Allen

family: Horn

full_name: Priscilla Horn

given: Priscilla

family: Maia

full_name: Mauricio Maia

given: Mauricio

family: Castro

full_name: Aide Castro

given: Aide

family: Peck

full_name: Melicent C. Peck

given: Melicent C.

family: Galanter

full_name: Joshua Galanter

given: Joshua

family: Chu

full_name: Tom Chu

given: Tom

family: Newton

full_name: Elizabeth M. Newton

given: Elizabeth M.

family: Tavel

full_name: Jorge A. Tavel

given: Jorge A.

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

location_country:
Peru
Belgium
Russian Federation
Taiwan
Ukraine
France
Poland
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: University Division of Infective and Tropical Diseases, University of Brescia, Italy

location_facility: Hospital de la Amistad Peru Corea II-2 Santa Rosa

location_facility: 5th Multifunctional Hospital for Active treatment

location_facility: Oddział Anestezjologii i Intensywnej Terapii;Wojewódzki Szpital Zespolony im. L. Rydygiera

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Royal Jubilee Hospital Victoria general Hospital

location_facility: Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace

location_facility: Service de réanimation médicale, Hôpital Bretonneau

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Municipal Institution City Clinical Infectious Diseases Hospital

location_facility: MHAT TOKUDA SOFIA/ICU-Intensive Care Unit

location_facility: Kaohsiung Medical University Hospital, Cancer Center

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: National Institute for Infectious Diseases "L. Spallanzani"

location_facility: Erasmus Medical Centre; Department of Virology L-359

location_facility: Centre Hospitalier de la Universite Laval

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Universitätsklinikum Frankfurt Goethe Universität

location_facility: Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hospital Univ. de Getafe.Servicio de Neurologia

location_facility: Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD

location_facility: Servicio de Medicina Intensiva Hospital Universitario la Fe

location_facility: Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk

location_facility: Clinica Divino Nino Jesus; Orden de Malta

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: King College Hospital NHS Foundation Trust

location_facility: MHAT Lyulin EAD, Department of internal diseases

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: Leeds General Infirmary, Anaesthetic Department, D Floor

location_facility: Service de Réanimation médicale - Bocage Central

location_facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD

location_facility: Municipal Healthcare Institution "City Hospital №2"

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

location_facility: Taunton and Somerset NHS Foundation Trust Musgrove Park Hospital

location_facility: Gelre Ziekenhuizen Apeldoorn; Hospitals Pharmacy

location_facility: A.O.U. S. Giovanni di Dio e Ruggi d'Aragona

location_facility: Anesthesia and Intensive Care Dept., Regional Hospital Liberec

location_facility: Hallym university Kangnam Sacred Heart Hospital; Infectious devision

location_facility: Centro de Especialidades Medicas Del Estado de Veracruz Dr Rafael Lucio

location_facility: Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

location_facility: Poltava Regional Clinical Infectious Hospital

location_facility: Centre de santé et de services sociaux de Trois-Rivières

location_facility: University hospital Ostrava, Clinic of infectious medicine

location_facility: University Hospital Modena, Intensive Care Unit

location_facility: Uppsala University Hospital, Department of Infectious Diseases

location_facility: University Multiprofile Hospital for Active Treatment "St. George"

location_facility: Hadasit Medical Research Services and Development Ltd

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Southampton University Hospitals NHS Trust

location_facility: St. Paul's Hospital, Providence Health Care

location_facility: LHSC - University Hospital; Research Pharmacy

location_facility: Municipal Institution Central City Hospital #1 City of Zhytomyr

title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR TREATMENT OF SEVERE INFLUENZA A INFECTION

summary: This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.


title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients

acronym: TIGRIS

summary: THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

ReferenceCitation: Pocock S, Brieger DB, Owen R, Chen J, Cohen MG, Goodman S, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Hedman K, Mellström C, Andersson Sundell K, Grieve R. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis. Open Heart. 2021 Feb;8(1). pii: e001499. doi: 10.1136/openhrt-2020-001499.

family: Pocock

full_name: Stuart Pocock

given: Stuart

family: Brieger

full_name: David B Brieger

given: David B

family: Owen

full_name: Ruth Owen

given: Ruth

family: Chen

full_name: Jiyan Chen

given: Jiyan

family: Cohen

full_name: Mauricio G Cohen

given: Mauricio G

family: Goodman

full_name: Shaun Goodman

given: Shaun

family: Granger

full_name: Christopher B Granger

given: Christopher B

family: Nicolau

full_name: José C Nicolau

given: José C

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Westermann

full_name: Dirk Westermann

given: Dirk

family: Yasuda

full_name: Satoshi Yasuda

given: Satoshi

family: Hedman

full_name: Katarina Hedman

given: Katarina

family: Mellström

full_name: Carl Mellström

given: Carl

family: Andersson Sundell

full_name: Karolina Andersson Sundell

given: Karolina

family: Grieve

full_name: Richard Grieve

given: Richard

currency_apc_doaj: GBP

journal_name: Open Heart

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

version: acceptedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Health-related quality of life 1–3 years post-myocardial infarction: its impact on prognosis

ReferenceCitation: Nicolau JC, Brieger D, Owen R, Furtado RHM, Goodman SG, Cohen MG, Simon T, Westermann D, Granger CB, Grieve R, Yasuda S, Chen J, Hedman K, Mellström C, Brandrup-Wognsen G, Pocock SJ. Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction. Clin Cardiol. 2020 Dec;43(12):1352-1361. doi: 10.1002/clc.23476. Epub 2020 Nov 4.

name: Instituto do Coração (InCor), Hospital das Clinicas da Faculdade de Medicina Universidade de São Paulo  São Paulo Brazil

full_name: José C. Nicolau

given: José C.

name: Concord Hospital and University of Sydney  Sydney Australia

name: London School of Hygiene and Tropical Medicine  London UK

name: Hospital Israelita Albert Einstein  São Paulo Brazil

name: Terrence Donnelly Heart Centre St Michael's Hospital, University of Toronto  Toronto Canada

name: University of Miami Miller School of Medicine  Miami Florida USA

name: Department of Clinical Pharmacology and Clinical Research Platform of East of Paris Assistance Publique‐Hopitaux de Paris (APHP)  Paris France

name: Sorbonne‐Université (UPMC‐Paris 06)  Paris France

name: Department of General and Interventional Cardiology University Heart Center Eppendorf  Hamburg Germany

name: German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Lübeck/Kiel  Hamburg Germany

name: Duke Clinical Research Institute Duke University Medical Center  Durham North Carolina USA

name: Department of Cardiovascular Medicine National Cerebral and Cardiovascular Center  Osaka Japan

name: Guangdong General Hospital, Provincial Key Laboratory of Coronary Disease  Guangzhou China

title: Diabetes association with self‐reported health, resource utilization, and prognosis post‐myocardial infarction

ReferenceCitation: Westermann D, Goodman SG, Nicolau JC, Requena G, Maguire A, Chen JY, Granger CB, Grieve R, Pocock SJ, Blankenberg S, Vega AM, Yasuda S, Simon T, Brieger D; TIGRIS Study Investigators. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study. Clin Cardiol. 2017 Dec;40(12):1197-1204. doi: 10.1002/clc.22837. Epub 2017 Dec 16.

name: Department of General and Interventional Cardiology; University Heart Center; Hamburg Germany

name: German Center for Cardiovascular Research (DZHK); Partner Site Hamburg/Lübeck/Kiel; Hamburg Germany

name: Terrence Donnelly Heart Centre, St Michael's Hospital; University of Toronto; Toronto Canada

name: Heart Institute (InCor); University of São Paulo Medical School; São Paulo Brazil

name: Oxon Epidemiology; London United Kingdom

name: Guangdong General Hospital; Provincial Key Laboratory of Coronary Disease; Guangzhou China

name: Duke Clinical Research Institute; Duke University Medical Center; Durham North Carolina

name: London School of Hygiene and Tropical Medicine; London United Kingdom

name: Medical Evidence and Observational Research; Global Medical Affairs; AstraZeneca Madrid Spain

name: National Cerebral and Cardiovascular Center; Osaka Japan

name: Assistance Publique-Hôpitaux de Paris (APHP); UPMC-Paris 06 University; Paris France

name: Concord Hospital and University of Sydney; Sydney Australia

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Goodman SG, Nicolau JC, Requena G, Maguire A, Blankenberg S, Chen JY, Granger CB, Grieve R, Pocock SJ, Simon T, Yasuda S, Vega AM, Brieger D; TIGRIS Study Investigators. Longer-term oral antiplatelet use in stable post-myocardial infarction patients: Insights from the long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease (TIGRIS) observational study. Int J Cardiol. 2017 Jun 1;236:54-60. doi: 10.1016/j.ijcard.2017.02.062. Epub 2017 Feb 21.

location_country:
Finland
Romania
Belgium
Australia
Denmark
India
France
Japan
Norway
Argentina
Canada
Korea, Republic of
Colombia
Netherlands
Portugal
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Venezuela
Spain
Turkey


title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

acronym: PIONEER AF-PCI

summary: The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

ReferenceCitation: Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial. Circ Cardiovasc Interv. 2019 Nov;12(11):e008160. doi: 10.1161/CIRCINTERVENTIONS.119.008160. Epub 2019 Nov 11.

name: Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.K., M.K.Y., T.N., C.M.G.).

family: Kerneis

full_name: Mathieu Kerneis

given: Mathieu

family: Yee

full_name: Megan K. Yee

given: Megan K.

name: Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, NY (R.M., J.L.H.).

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Nafee

full_name: Tarek Nafee

given: Tarek

name: Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Germany (C.B.).

family: Bode

full_name: Christoph Bode

given: Christoph

family: Halperin

full_name: Jonathan L. Halperin

given: Jonathan L.

name: Duke Clinical Research Institute, Durham, NC (E.D.P.).

family: Peterson

full_name: Eric D. Peterson

given: Eric D.

name: Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands (F.W.A.V.).

family: Verheugt

full_name: Freek W.A. Verheugt

given: Freek W.A.

name: Janssen Pharmaceuticals, Inc, Beerse, Belgium, Inc, Titusville, NJ (P.W.).

family: Wildgoose

full_name: Peter Wildgoose

given: Peter

name: Bayer Pharmaceuticals, Inc, Berlin, Germany (M.v.E.).

family: van Eickels

full_name: Martin van Eickels

given: Martin

name: Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.).

family: Lip

full_name: Gregory Y.H. Lip

given: Gregory Y.H.

name: Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ (M.C.).

full_name: Marc Cohen

given: Marc

name: Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, United Kingdom (K.A.A.F.).

family: Fox

full_name: Keith A.A. Fox

given: Keith A.A.

family: Gibson

full_name: C. Michael Gibson

given: C. Michael

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

full_name: William J. Gibson

given: William J.

family: Travis

full_name: Ryan Travis

given: Ryan

full_name: Megan Yee

given: Megan

ReferenceCitation: Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Association of International Normalized Ratio Stability and Bleeding Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Feb;12(2):e007124. doi: 10.1161/CIRCINTERVENTIONS.118.007124.

name: Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY (R.M., J.L.H.).

name: Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom (G.Y.H.L.).

name: Division of Cardiology, Newark Beth Israel Medical Center, NJ (M.C.).

ReferenceCitation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

repositories_institution: Aalborg Universitet - VBN Forskningsportal

title: Safety and efficacy of non–vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial

ReferenceCitation: Chi G, Yee MK, Kalayci A, Kerneis M, AlKhalfan F, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention. J Thromb Thrombolysis. 2018 Oct;46(3):346-350. doi: 10.1007/s11239-018-1703-5.

ReferenceCitation: Kerneis M, Gibson CM, Chi G, Mehran R, AlKhalfan F, Talib U, Pahlavani S, Mir M, Bode C, Halperin JL, Nafee T, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Fox KAA, Cohen M. Effect of Procedure and Coronary Lesion Characteristics on Clinical Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the PIONEER AF-PCI Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):626-634. doi: 10.1016/j.jcin.2017.11.009. Epub 2018 Mar 14.

ReferenceCitation: Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, Korjian S, Daaboul Y, Lip GY, Cohen M, Husted S, Peterson ED, Fox KA. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi: 10.1056/NEJMoa1611594. Epub 2016 Nov 14.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Gibson CM, Pinto DS, Chi G, Arbetter D, Yee M, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Burton P, van Eickels M, Korjian S, Daaboul Y, Jain P, Lip GY, Cohen M, Peterson ED, Fox KA. Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy. Circulation. 2017 Jan 24;135(4):323-333. doi: 10.1161/CIRCULATIONAHA.116.025783. Epub 2016 Nov 14. Erratum in: Circulation. 2017 Mar 21;135(12 ):e789.

name: From Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.M.G., D.S.P., G.C., D.A., M.Y., S.K., Y.D., P.J.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M., J.H.); Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany (C.B.); Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (F.W.A.V.); Janssen Pharmaceuticals, Inc,...

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

evidence: oa repository (via OAI-PMH title and first author match)

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Gibson CM, Mehran R, Bode C, Halperin J, Verheugt F, Wildgoose P, van Eickels M, Lip GY, Cohen M, Husted S, Peterson E, Fox K. An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI). Am Heart J. 2015 Apr;169(4):472-8.e5. doi: 10.1016/j.ahj.2014.12.006. Epub 2014 Dec 20.

title: An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI)

location_country:
Malaysia
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Netherlands
Bulgaria
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
Turkey