title: A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

acronym: BOREALIS-AF

summary: The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Buller HR, Halperin J, Hankey GJ, Pillion G, Prins MH, Raskob GE. Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis-Atrial Fibrillation Study. J Thromb Haemost. 2014 Jun;12(6):824-30. doi: 10.1111/jth.12546.

name: Department of Vascular Medicine; Academic Medical Center; Amsterdam the Netherlands

family: Buller

full_name: H. R. Buller

given: H. R.

name: The Cardiovascular Institute; Mount Sinai Medical Center; New York NY USA

family: Halperin

full_name: J. Halperin

given: J.

name: School of Medicine and Pharmacology; The University of Western Australia; Perth WA Australia

name: Department of Neurology; Sir Charles Gairdner Hospital; Perth WA Australia

family: Hankey

full_name: G. J. Hankey

given: G. J.

name: Sanofi-Aventis Recherché et Développement; Chilly Mazarin France

family: Pillion

full_name: G. Pillion

given: G.

name: Department of Epidemiology; Maasticht University Medical Centre; Maastricht the Netherlands

family: Prins

full_name: M. H. Prins

given: M. H.

name: The University of Oklahoma Health Sciences Center; Oklahoma city OK USA

family: Raskob

full_name: G. E. Raskob

given: G. E.

journal_name: Journal of Thrombosis and Haemostasis

oa_host_type: publisher

evidence: open (via free pdf)

lead_sponsor: Sanofi

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intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Ipsen

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Brazil
Sweden
Serbia
Netherlands
Finland
France
Poland
Greece
Norway
Romania
Russian Federation
Denmark
Latvia
Korea, Republic of

acronym: LEAD

location_facility: Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division

location_facility: Hôpital Du Cluzeau - Service de Médecine B

location_facility: Polykliniki Hospital - Department of Endocrinology

location_facility: B IKA Panagia Hospital - Department of Endocrinology

location_facility: Department of Medicine, Haukeland Hospital Jonas Lies

location_facility: Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine

location_facility: Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4

location_facility: Skane University Hospital, Department of Endocrinology

location_facility: CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B

location_facility: P. Stradins Clinical University Hospital - Department of Endocrinology

location_facility: Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9

location_facility: I.M. Sechenov Moscow Medical Academy - Endocrinology Department

location_facility: University of Medicine and Pharmacy Iuliu Hatieganu

location_facility: Hôpital Neurologique - Pierre Wertheimer

location_facility: Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department

location_facility: Righospitalet - University Department of Endocrinology & Internal Medicine P

location_facility: Seoul National University hospital, 28 Yongon-dong Chongno-gu

location_facility: Sungkyunkwan University Samsung Medical Center

location_facility: Yonsei University Severance Hospital - Department of Endocrinology and Metabolism

location_facility: Evangelismos Hospital - Department of Endocrinology

location_facility: Hôpital Avicenne - Bâtiment Madeleine Breis

location_facility: Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13

location_facility: Erasmus Medical Centre - Department of Endocrinology

location_facility: UMC Utrecht - Department of Endocrinology, Heidelberglaan 100

location_facility: University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17

location_facility: Hôpital Haut Lévêque - Unité de soins normalisés

location_facility: Hôpital de Hautepierre, Service de Médecine Interne et Nutrition

location_facility: Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition

location_facility: Odense University Hospital - Department of Endocrinology

location_facility: Hopital Pitié-Salpêtrière - Service d'Endocrinologie

location_facility: Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna

location_facility: Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism

location_facility: Arhus University Hospital - Department of Medicinsk AVd M

location_facility: Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center

location_facility: Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon

location_facility: CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition

location_facility: Metaxa Hospital - Department of Endocrinology

location_facility: Hôpital du Bocage Sud - Service d'Endocrinologie

location_facility: Hôpital Archet 1 - Service d'Endocrinologie

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

summary: The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER®, RE-COVER™ II, and RE-MEDY™. Vasc Med. 2016 Dec;21(6):506-514. Epub 2016 Nov 1.

ReferenceCitation: Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

name: From the Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, C.K.); Department of Hematology, Karolinska University Hospital, Stockholm, Sweden (S.S.); Thrombosis Research Institute and University College London, London, UK (A.K.K.); Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.Z.G.); Medical Division 2, Municipal Hospital Friedrichstadt, Dresden, Germany (S. Schellong); Department of Medicine,...

family: Schulman

full_name: Sam Schulman

given: Sam

sequence: first

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

sequence: additional

family: Goldhaber

full_name: Samuel Z. Goldhaber

given: Samuel Z.

family: Schellong

full_name: Sebastian Schellong

given: Sebastian

family: Eriksson

full_name: Henry Eriksson

given: Henry

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Christiansen

full_name: Anita Vedel Christiansen

given: Anita Vedel

family: Friedman

full_name: Jeffrey Friedman

given: Jeffrey

family: Le Maulf

full_name: Florence Le Maulf

given: Florence

family: Peter

full_name: Nuala Peter

given: Nuala

family: Kearon

full_name: Clive Kearon

given: Clive

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

name: From the Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden (A.M., S.S.); the Department of Medicine, Soonchunhyang University Gumi’s Hospital, North Kyungsang Province, South Korea (H.-G-H.); McMaster University, Population Health Research Institute, Hamilton, ON, Canada (S.J.C., J.W.E., S.Y.); Lankenau Medical Center, Thomas Jefferson Medical College, Wynnewood, PA (M.D.E.); Uppsala Clinical Research Center and Department of Medical...

family: Majeed

full_name: Ammar Majeed

given: Ammar

family: Hwang

full_name: Hun-Gyu Hwang

given: Hun-Gyu

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

family: Ezekowitz

full_name: Michael D. Ezekowitz

given: Michael D.

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Fraessdorf

full_name: Mandy Fraessdorf

given: Mandy

family: Yusuf

full_name: Salim Yusuf

given: Salim

title: Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin

location_country:
Malaysia
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
India
France
Poland
Thailand
Slovakia
Norway
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Philippines
Bulgaria
Singapore
Hungary
China
United States
United Kingdom
Italy
Brazil
Israel
New Zealand
Spain
Turkey

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title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.


title: A Non-Interventional, Post Authorisation Safety Study, to Continuously Monitor Safety and Pregnancy Outcomes in a Cohort of At-Risk Essential Thrombocythaemia (ET) Subjects Exposed to Xagrid Compared to Other Conventional Cytoreductive Treatments

summary: This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Birgegård G, Besses C, Griesshammer M, Gugliotta L, Harrison CN, Hamdani M, Wu J, Achenbach H, Kiladjian JJ. Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study. Haematologica. 2018 Jan;103(1):51-60. doi: 10.3324/haematol.2017.174672. Epub 2017 Oct 27.

family: Birgegård

full_name: Gunnar Birgegård

given: Gunnar

family: Besses

full_name: Carlos Besses

given: Carlos

family: Griesshammer

full_name: Martin Griesshammer

given: Martin

family: Gugliotta

full_name: Luigi Gugliotta

given: Luigi

family: Harrison

full_name: Claire N. Harrison

given: Claire N.

family: Hamdani

full_name: Mohamed Hamdani

given: Mohamed

family: Wu

full_name: Jingyang Wu

given: Jingyang

family: Achenbach

full_name: Heinrich Achenbach

given: Heinrich

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

evidence: oa repository (via pmcid lookup)

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Gugliotta L, Besses C, Griesshammer M, Harrison C, Kiladjian JJ, Coll R, Smith J, Abhyankar B, Birgegård G. Combination therapy of hydroxycarbamide with anagrelide in patients with essential thrombocythemia in the evaluation of Xagrid(R) efficacy and long-term safety study. Haematologica. 2014 Apr;99(4):679-87. doi: 10.3324/haematol.2012.083097. Epub 2013 Dec 13.

full_name: L. Gugliotta

given: L.

full_name: C. Besses

given: C.

full_name: M. Griesshammer

given: M.

full_name: C. Harrison

full_name: J.-J. Kiladjian

family: Coll

full_name: R. Coll

ReferenceCitation: Besses C, Kiladjian JJ, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Abhyankar B, Birgegård G. Cytoreductive treatment patterns for essential thrombocythemia in Europe. Analysis of 3643 patients in the EXELS study. Leuk Res. 2013 Feb;37(2):162-8. doi: 10.1016/j.leukres.2012.11.004. Epub 2012 Nov 29.

ReferenceCitation: Kiladjian JJ, Besses C, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Birgegård G. Efficacy and safety of cytoreductive therapies in patients with essential thrombocythaemia aged >80 years: an interim analysis of the EXELS study. Clin Drug Investig. 2013 Jan;33(1):55-63. doi: 10.1007/s40261-012-0042-0.

title: Efficacy and Safety of Cytoreductive Therapies in Patients with Essential Thrombocythaemia Aged >80 Years: An Interim Analysis of the EXELS Study

location_country:
Italy
Sweden
Netherlands
Spain
Cyprus
Finland
France
Greece
Norway
Ireland
Portugal
Denmark
Germany
United Kingdom

location_facility: Schwerpunktpraxis fur Hamatologie und Internistische Onkologie

location_facility: Padiglione ex-oncologico Ospedale S.Maria

location_facility: Ippokration Hospital D Clinic of Internal Medicine

location_facility: Gemeinschaftspraxis fur Hamatologie und Internistische Onkologie

location_facility: Praxis und Tagesklinik fur Internistische Onkologie

location_facility: CHU de Limoges - Hopital Universitaire Dupuytren

location_facility: Hospital Clinico Universitario Salamanca

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Praxis Dr. Heinrich, Dr. Brudler, Dr. Bangerter

location_facility: CHU de Grenoble Hopital Albert Michallon

location_facility: Azienda Ospedaliera Ospedali Riuniti Foggia