title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

acronym: ARISTOTLE

summary: The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

primary_purpose: Prevention

ReferenceCitation: Pol T, Hijazi Z, Lindbäck J, Oldgren J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Siegbahn A, Wallentin L. Using multimarker screening to identify biomarkers associated with cardiovascular death in patients with atrial fibrillation. Cardiovasc Res. 2021 Aug 6. pii: cvab262. doi: 10.1093/cvr/cvab262. [Epub ahead of print]

name: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala Science Park, SE-752 37 Uppsala, Sweden

name: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

family: Pol

full_name: Tymon Pol

given: Tymon

family: Hijazi

full_name: Ziad Hijazi

given: Ziad

family: Lindbäck

full_name: Johan Lindbäck

given: Johan

family: Oldgren

full_name: Jonas Oldgren

given: Jonas

name: Duke Clinical Research Institute, Duke Health, Durham, NC, USA

family: Alexander

full_name: John H Alexander

given: John H

name: Population Health Research Institute, Hamilton, Canada

family: Connolly

full_name: Stuart J Connolly

given: Stuart J

family: Eikelboom

full_name: John W Eikelboom

given: John W

name: Thomas Jefferson University, Philadelphia, PA, USA

name: Cardiovascular Medicine, Lankenau Institute for Medical Research, Wynnewood, PA, USA

family: Ezekowitz

full_name: Michael D Ezekowitz

given: Michael D

family: Granger

full_name: Christopher B Granger

given: Christopher B

family: Lopes

full_name: Renato D Lopes

given: Renato D

family: Yusuf

full_name: Salim Yusuf

given: Salim

name: Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden

family: Siegbahn

full_name: Agneta Siegbahn

given: Agneta

family: Wallentin

full_name: Lars Wallentin

given: Lars

journal_name: Cardiovascular Research

title: Using multimarker screening to identify biomarkers associated with cardiovascular death in patients with atrial fibrillation

ReferenceCitation: Pol T, Hijazi Z, Lindbäck J, Alexander JH, Bahit MC, De Caterina R, Eikelboom JW, Ezekowitz MD, Gersh BJ, Granger CB, Hylek EM, Lopes R, Siegbahn A, Wallentin L. Evaluation of the prognostic value of GDF-15, ABC-AF-bleeding score and ABC-AF-death score in patients with atrial fibrillation across different geographical areas. Open Heart. 2021 Mar;8(1). pii: e001471. doi: 10.1136/openhrt-2020-001471.

family: Bahit

full_name: M Cecilia Bahit

given: M Cecilia

family: De Caterina

full_name: Raffaele De Caterina

given: Raffaele

repository_institution: Uppsala University - Uppsala University Publications

repositories_institution: Uppsala University - Uppsala University Publications

title: Evaluation of the prognostic value of GDF-15, ABC-AF-bleeding score and ABC-AF-death score in patients with atrial fibrillation across different geographical areas

ReferenceCitation: Hijazi Z, Wallentin L, Lindbäck J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Pol T, Yusuf S, Oldgren J, Siegbahn A. Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation. J Am Heart Assoc. 2020 Dec 15;9(24):e018984. doi: 10.1161/JAHA.120.018984. Epub 2020 Dec 9.

name: Department of Medical Sciences Cardiology Uppsala University Uppsala Sweden

name: Uppsala Clinical Research Center Uppsala University Uppsala Sweden

name: Duke Clinical Research InstituteDuke Health Durham NC

name: Population Health Research Institute Hamilton ON Canada

name: Thomas Jefferson University Philadelphia PA

name: Cardiovascular Medicine Lankenau Institute for Medical Research Wynnewood PA

name: Department of Medical Sciences Clinical Chemistry and Science for Life Laboratory Uppsala University Uppsala Sweden

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation

ReferenceCitation: Wallentin L, Lindbäck J, Eriksson N, Hijazi Z, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Oldgren J, Siegbahn A. Angiotensin-converting enzyme 2 (ACE2) levels in relation to risk factors for COVID-19 in two large cohorts of patients with atrial fibrillation. Eur Heart J. 2020 Nov 1;41(41):4037-4046. doi: 10.1093/eurheartj/ehaa697.

name: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden

name: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada

name: Thomas Jefferson Medical College and the Heart Center, Wynnewood, PA, USA

name: Duke Clinical Research Institute, Duke University Medical Center, Duke Health, Durham, NC, USA

title: Angiotensin-converting enzyme 2 (ACE2) levels in relation to risk factors for COVID-19 in two large cohorts of patients with atrial fibrillation

ReferenceCitation: Hijazi Z, Granger CB, Hohnloser SH, Westerbergh J, Lindbäck J, Alexander JH, Keltai M, Parkhomenko A, López-Sendón JL, Lopes RD, Siegbahn A, Wallentin L. Association of Different Estimates of Renal Function With Cardiovascular Mortality and Bleeding in Atrial Fibrillation. J Am Heart Assoc. 2020 Sep 15;9(18):e017155. doi: 10.1161/JAHA.120.017155. Epub 2020 Aug 31.

name: Duke Clinical Research Institute Duke University School of Medicine Durham NC

name: J. W. Goethe‐University Frankfurt Germany

name: Hungarian Institute of Cardiology Semmelweis University Budapest Hungary

name: Hospital Universitario La Paz, IdiPaz Madrid Spain

name: Department of Medical Sciences Clinical Chemistry Uppsala University Uppsala Sweden

title: Association of Different Estimates of Renal Function With Cardiovascular Mortality and Bleeding in Atrial Fibrillation

ReferenceCitation: Zeitouni M, Giczewska A, Alexander JH. Reply: Specifics of Dose Modification in ARISTOTLE. J Am Coll Cardiol. 2020 Jul 7;76(1):128-129. doi: 10.1016/j.jacc.2020.05.013.

journal_name: Journal of the American College of Cardiology

title: Reply

ReferenceCitation: Røsjø H, Hijazi Z, Omland T, Westerbergh J, Lyngbakken MN, Alexander JH, Gersh BJ, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial. J Intern Med. 2020 Aug;288(2):248-259. doi: 10.1111/joim.13072. Epub 2020 May 18.

name: Division of Research and Innovation Akershus University Hospital Lørenskog Norway

name: Institute of Clinical Medicine University of Oslo Oslo Norway

name: Department of Cardiology Division of Medicine Akershus University Hospital Lørenskog Norway

name: Duke Clinical Research InstituteDuke Health Durham NC USA

name: Mayo Clinic College of Medicine Rochester MN USA

name: Boston University Medical Center Boston MA USA

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

title: Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial

ReferenceCitation: Zeitouni M, Giczewska A, Lopes RD, Wojdyla DM, Christersson C, Siegbahn A, De Caterina R, Steg PG, Granger CB, Wallentin L, Alexander JH; ARISTOTLE Investigators. Clinical and Pharmacological Effects of Apixaban Dose Adjustment in the ARISTOTLE Trial. J Am Coll Cardiol. 2020 Mar 17;75(10):1145-1155. doi: 10.1016/j.jacc.2019.12.060.

title: Clinical and Pharmacological Effects of Apixaban Dose Adjustment in the ARISTOTLE Trial

ReferenceCitation: Stanifer JW, Pokorney SD, Chertow GM, Hohnloser SH, Wojdyla DM, Garonzik S, Byon W, Hijazi Z, Lopes RD, Alexander JH, Wallentin L, Granger CB. Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease. Circulation. 2020 Apr 28;141(17):1384-1392. doi: 10.1161/CIRCULATIONAHA.119.044059. Epub 2020 Mar 12.

name: Munson Nephrology, Munson Healthcare, Traverse City, MI (J.W.S.).

name: Division of Cardiology, Department of Medicine, Duke Health (S.D.P., J.H.A., C.B.G.), Duke University School of Medicine, Durham, NC.

name: Duke Clinical Research Institute (S.D.P., D.M.W., R.D.L., J.H.A., C.B.G.), Duke University School of Medicine, Durham, NC.

name: Division of Nephrology, Stanford University School of Medicine, CA (G.M.C.).

name: Johann Wolfgang Goethe University, Frankfurt, Germany (S.H.H.).

name: Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb Company, Princeton, NJ (S.G.).

name: Global Product Development Clinical Pharmacology, Pfizer, Inc, Groton, CT (W.B.).

name: Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center (Z.H., L.W.), Uppsala University, Sweden.

title: Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease

ReferenceCitation: Garcia DA, Fisher DA, Mulder H, Wruck L, De Caterina R, Halvorsen S, Granger CB, Held C, Wallentin L, Alexander JH, Lopes RD. Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Am Heart J. 2020 Mar;221:1-8. doi: 10.1016/j.ahj.2019.10.013. Epub 2019 Oct 31.

title: Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial

ReferenceCitation: Dalgaard F, Mulder H, Wojdyla DM, Lopes RD, Held C, Alexander JH, De Caterina R, Washam JB, Hylek EM, Garcia DA, Gersh BJ, Wallentin L, Granger CB, Al-Khatib SM. Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial. Circulation. 2020 Jan 7;141(1):10-20. doi: 10.1161/CIRCULATIONAHA.119.041296. Epub 2019 Nov 21.

name: Department of Cardiology, Herlev and Gentofte Hospital, Hellerup, Denmark (F.D.).

name: Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).

name:
Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden
(C.H., L.W.).

name: Institute of Cardiology, University of Pisa, Italy (R.D.).

name: Boston University School of Medicine, MA (E.M.H.).

name: University of Washington School of Medicine, Seattle, (D.A.G.).

name: Mayo Clinic College of Medicine, Rochester, MN (B.J.G.).

title: Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial

ReferenceCitation: Goldstein SA, Green J, Huber K, Wojdyla DM, Lopes RD, Alexander JH, Vinereanu D, Wallentin L, Granger CB, Al-Khatib SM. Characteristics and Outcomes of Atrial Fibrillation in Patients With Thyroid Disease (from the ARISTOTLE Trial). Am J Cardiol. 2019 Nov 1;124(9):1406-1412. doi: 10.1016/j.amjcard.2019.07.046. Epub 2019 Aug 7.

title: Characteristics and Outcomes of Atrial Fibrillation in Patients With Thyroid Disease (from the ARISTOTLE Trial)

ReferenceCitation: Guimarães PO, Pokorney SD, Lopes RD, Wojdyla DM, Gersh BJ, Giczewska A, Carnicelli A, Lewis BS, Hanna M, Wallentin L, Vinereanu D, Alexander JH, Granger CB. Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial. Clin Cardiol. 2019 May;42(5):568-571. doi: 10.1002/clc.23178. Epub 2019 Apr 9.

name: Duke Clinical Research InstituteDuke University School of Medicine Durham North Carolina

name: Division of Cardiovascular DiseasesMayo Clinic College of Medicine Rochester Minnesota

name: Department of Biomedical Engineering, Faculty of ElectronicsTelecommunications and Informatics, Gdansk University of Technology Poland

name: Department of Cardiovascular MedicineLady Davis Carmel Medical Center Haifa Israel

name: Bristol‐Myers Squibb Princeton New Jersey

name: Uppsala Clinical Research Center, Department of Medical Sciences, CardiologyUppsala University Uppsala Sweden

name: Department of CardiologyUniversity of Medicine and Pharmacy Carol Davila, University and Emergency Hospital Bucharest Romania

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

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

title: Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial

ReferenceCitation: Washam JB, Hohnloser SH, Lopes RD, Wojdyla DM, Vinereanu D, Alexander JH, Gersh BJ, Hanna M, Horowitz J, Hylek EM, Xavier D, Verheugt FWA, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators. Interacting medication use and the treatment effects of apixaban versus warfarin: results from the ARISTOTLE Trial. J Thromb Thrombolysis. 2019 Apr;47(3):345-352. doi: 10.1007/s11239-019-01823-y.

name: for the ARISTOTLE Committees and Investigators

title: Interacting medication use and the treatment effects of apixaban versus warfarin: results from the ARISTOTLE Trial

ReferenceCitation: Hohnloser SH, Fudim M, Alexander JH, Wojdyla DM, Ezekowitz JA, Hanna M, Atar D, Hijazi Z, Bahit MC, Al-Khatib SM, Lopez-Sendon JL, Wallentin L, Granger CB, Lopes RD. Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight. Circulation. 2019 May 14;139(20):2292-2300. doi: 10.1161/CIRCULATIONAHA.118.037955.

name: Johann Wolfgang Goethe University, Frankfurt, Germany (S.G.G.).

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.H.A., D.M.W., S.M.A.-K., C.B.G., R.D.L.).

name: University of Alberta, Alberta, Canada (J.A.E.).

name: Bristol-Myers Squibb, Princeton, NJ (M.H.).

name: Uppsala Clinical Research Center, Uppsala University, Sweden (Z.H., L.W.).

name: Fundación INECO Rosario, Department of Cardiology, INECO Neurociencias Orono, Santa Fe, Argentina (M.C.B.).

name: Hospital Universitario La Paz, Madrid, Spain (J.L.L.-S.).

title: Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight

ReferenceCitation: Alexander KP, Brouwer MA, Mulder H, Vinereanu D, Lopes RD, Proietti M, Al-Khatib SM, Hijazi Z, Halvorsen S, Hylek EM, Verheugt FWA, Alexander JH, Wallentin L, Granger CB; ARISTOTLE Investigators. Outcomes of apixaban versus warfarin in patients with atrial fibrillation and multi-morbidity: Insights from the ARISTOTLE trial. Am Heart J. 2019 Feb;208:123-131. doi: 10.1016/j.ahj.2018.09.017. Epub 2018 Nov 22.

title: Outcomes of apixaban versus warfarin in patients with atrial fibrillation and multi-morbidity: Insights from the ARISTOTLE trial

ReferenceCitation: Sandhu RK, Ezekowitz JA, Hijazi Z, Westerbergh J, Aulin J, Alexander JH, Granger CB, Halvorsen S, Hanna MS, Lopes RD, Siegbahn A, Wallentin L. Obesity paradox on outcome in atrial fibrillation maintained even considering the prognostic influence of biomarkers: insights from the ARISTOTLE trial. Open Heart. 2018 Nov 1;5(2):e000908. doi: 10.1136/openhrt-2018-000908. eCollection 2018.

title: Obesity paradox on outcome in atrial fibrillation maintained even considering the prognostic influence of biomarkers: insights from the ARISTOTLE trial

ReferenceCitation: Christersson C, Wallentin L, Andersson U, Alexander JH, Alings M, De Caterina R, Gersh BJ, Granger CB, Halvorsen S, Hanna M, Huber K, Hylek EM, Lopes RD, Oh BH, Siegbahn A. Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation. Heart. 2019 Feb;105(3):235-242. doi: 10.1136/heartjnl-2018-313351. Epub 2018 Sep 12.

title: Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation

ReferenceCitation: Horowitz JD, De Caterina R, Heresztyn T, Alexander JH, Andersson U, Lopes RD, Steg PG, Hylek EM, Mohan P, Hanna M, Jansky P, Granger CB, Wallentin L; ARISTOTLE Investigators. Asymmetric and Symmetric Dimethylarginine Predict Outcomes in Patients With Atrial Fibrillation: An ARISTOTLE Substudy. J Am Coll Cardiol. 2018 Aug 14;72(7):721-733. doi: 10.1016/j.jacc.2018.05.058.

title: Asymmetric and Symmetric Dimethylarginine Predict Outcomes in Patients With Atrial Fibrillation

ReferenceCitation: Sharma A, Hijazi Z, Andersson U, Al-Khatib SM, Lopes RD, Alexander JH, Held C, Hylek EM, Leonardi S, Hanna M, Ezekowitz JA, Siegbahn A, Granger CB, Wallentin L. Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation. Circulation. 2018 Oct 16;138(16):1666-1676. doi: 10.1161/CIRCULATIONAHA.118.034125.

name: Duke Clinical Research Institute, Duke University, Durham, NC (A.S., S.M.A.-K., R.D.L., J.H.A., C.B.G.).

name: Department of Medical Sciences and Cardiology, Uppsala University, Sweden (Z.H., U.A., C.H., A.S., L.W.).

name: Uppsala Clinical Research Centre, Uppsala University, Sweden (Z.H., U.A., C.H., A.S., L.W.). Boston University Medical Center, MA (E.M.H.).

name: Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy (S.L.).

name: Canadian VIGOUR Centre, Department of Medicine, University of Alberta, Edmonton, Canada (A.S., J.A.E.).

title: Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation

ReferenceCitation: Kopin D, Jones WS, Sherwood MW, Wojdyla DM, Wallentin L, Lewis BS, Verheugt FWA, Vinereanu D, Bahit MC, Halvorsen S, Huber K, Parkhomenko A, Granger CB, Lopes RD, Alexander JH. Percutaneous coronary intervention and antiplatelet therapy in patients with atrial fibrillation receiving apixaban or warfarin: Insights from the ARISTOTLE trial. Am Heart J. 2018 Mar;197:133-141. doi: 10.1016/j.ahj.2017.11.005. Epub 2017 Nov 10.

title: Percutaneous coronary intervention and antiplatelet therapy in patients with atrial fibrillation receiving apixaban or warfarin: Insights from the ARISTOTLE trial

ReferenceCitation: Pol T, Held C, Westerbergh J, Lindbäck J, Alexander JH, Alings M, Erol C, Goto S, Halvorsen S, Huber K, Hanna M, Lopes RD, Ruzyllo W, Granger CB, Hijazi Z. Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial. J Am Heart Assoc. 2018 Feb 1;7(3). pii: e007444. doi: 10.1161/JAHA.117.007444.

name: Duke Clinical Research Institute, Duke Health, Durham, NC

name: Working Group on Cardiovascular Research the Netherlands, Utrecht, The Netherlands

name: Faculty of Medicine, Ankara University, Ankara, Turkey

name: Department of Medicine, School of Medicine, Tokai University, Isehara, Japan

name: Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway

name: 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenshopital, Vienna, Austria

name: Medical School, Sigmund Freud University, Vienna, Austria

title: Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial

ReferenceCitation: Goto S, Merrill P, Wallentin L, Wojdyla DM, Hanna M, Avezum A, Easton JD, Harjola VP, Huber K, Lewis BS, Parkhomenko A, Zhu J, Granger CB, Lopes RD, Alexander JH. Antithrombotic therapy use and clinical outcomes following thrombo-embolic events in patients with atrial fibrillation: insights from ARISTOTLE. Eur Heart J Cardiovasc Pharmacother. 2018 Apr 1;4(2):75-81. doi: 10.1093/ehjcvp/pvy002.

name: Department of Medicine (Cardiology), Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan

name: Department of Statistics, Duke Clinical Research Institute, Duke Health, 2400 Pratt Street, Durham, NC 27705, USA

name: Division of Cardiology, Department of Medical Sciences, Uppsala Clinical Research Center, Dag Hammarskjöldsv 38, Uppsala Science Park, Uppsala University, 751 85 Uppsala, Sweden

name: Bristol-Myers Squibb, 3551 Lawrenceville Princeton, Lawrence Township, NJ 08648, USA

name: Research Division, Dante Pazzanese Institute of Cardiology, Av. Dante Pazzanese, 500 - Vila Mariana, São Paulo - SP, 04012-909, Brazil

name: Department of Neurology, University of California San Francisco, Box 0663, 675 Nelson Rising Lane, 412 San Francisco, CA 94158, USA

name: Division of Emergency Care, Department of Medicine, Helsinki University Central Hospital, PO Box 340, Helsinki 00029 HUS, Finland

name: Department of Cardiology, Wilhelminenspital, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria

name: Department of Cardiology, Lady Davis Carmel Medical Center, The Ruth and Bruce Rappaport School of Medicine of the Technion, Mikhal St 7, Haifa 3436212, Israel

name: Department of Cardiology, Institute of Cardiology, Narodnoho Opolchennya St, 5, Kiev, Ukraine 02000

name: Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke Health, 2400 Pratt Street, Durham, NC 27705, USA

name: Duke Clinical Research Institute, Duke Health, 2400 Pratt Street, Durham, NC 27705, USA

journal_name: European Heart Journal - Cardiovascular Pharmacotherapy

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories: HELDA - Digital Repository of the University of Helsinki

title: Antithrombotic therapy use and clinical outcomes following thrombo-embolic events in patients with atrial fibrillation: insights from ARISTOTLE

ReferenceCitation: Vinereanu D, Wang A, Mulder H, Lopes RD, Jansky P, Lewis BS, Gersh BJ, Avezum A, Hanna M, Held C, Wallentin L, Granger CB, Alexander JH. Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease. Heart. 2018 Aug;104(15):1292-1299. doi: 10.1136/heartjnl-2017-312272. Epub 2018 Jan 19.

title: Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

ReferenceCitation: Rao MP, Vinereanu D, Wojdyla DM, Alexander JH, Atar D, Hylek EM, Hanna M, Wallentin L, Lopes RD, Gersh BJ, Granger CB; Apixaban for Reduction in Stroke Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Investigators. Clinical Outcomes and History of Fall in Patients with Atrial Fibrillation Treated with Oral Anticoagulation: Insights From the ARISTOTLE Trial. Am J Med. 2018 Mar;131(3):269-275.e2. doi: 10.1016/j.amjmed.2017.10.036. Epub 2017 Nov 6.

title: Clinical Outcomes and History of Fall in Patients with Atrial Fibrillation Treated with Oral Anticoagulation: Insights From the ARISTOTLE Trial

ReferenceCitation: Vinereanu D, Lopes RD, Mulder H, Gersh BJ, Hanna M, de Barros E Silva PGM, Atar D, Wallentin L, Granger CB, Alexander JH; ARISTOTLE Investigators. Echocardiographic Risk Factors for Stroke and Outcomes in Patients With Atrial Fibrillation Anticoagulated With Apixaban or Warfarin. Stroke. 2017 Dec;48(12):3266-3273. doi: 10.1161/STROKEAHA.117.017574. Epub 2017 Oct 31.

name: From the University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania (D.V.); Duke Clinical Research Institute (C.B.G., J.H.A.), Duke University School of Medicine, Durham, NC (R.D.L., H.M.); Division of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, MN (B.J.G.); Bristol-Myers Squibb, Princeton, NJ (M.H.); Brazilian Clinical Research Institute, São Paulo, Brazil (P.G.M.d.B.e.S.); Oslo University Hospital, Norway (D.A.); and Uppsala...

title: Echocardiographic Risk Factors for Stroke and Outcomes in Patients With Atrial Fibrillation Anticoagulated With Apixaban or Warfarin

ReferenceCitation: Hijazi Z, Oldgren J, Lindbäck J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Yusuf S, Granger CB, Siegbahn A, Wallentin L; ARISTOTLE and RE-LY Investigators. A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score. Eur Heart J. 2018 Feb 7;39(6):477-485. doi: 10.1093/eurheartj/ehx584.

name: Boston University Medical Center, Boston, MA, USA

title: A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score

ReferenceCitation: Hijazi Z, Lindahl B, Oldgren J, Andersson U, Lindbäck J, Granger CB, Alexander JH, Gersh BJ, Hanna M, Harjola VP, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Repeated Measurements of Cardiac Biomarkers in Atrial Fibrillation and Validation of the ABC Stroke Score Over Time. J Am Heart Assoc. 2017 Jun 23;6(6). pii: e004851. doi: 10.1161/JAHA.116.004851.

name: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala Sweden

name: Duke University Medical Center, Durham, NC

name: Mayo Clinic College of Medicine, Rochester, MN

name: Division of Emergency Care, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland

name: Boston University Medical Center, Boston, MA

repositories_institution:
PubMed Central - Europe PMC
University of Helsinki - Helda

title: Repeated Measurements of Cardiac Biomarkers in Atrial Fibrillation and Validation of the ABC Stroke Score Over Time

ReferenceCitation: Lopes RD, Guimarães PO, Kolls BJ, Wojdyla DM, Bushnell CD, Hanna M, Easton JD, Thomas L, Wallentin L, Al-Khatib SM, Held C, Gabriel Melo de Barros E Silva P, Alexander JH, Granger CB, Diener HC. Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation therapy. Blood. 2017 Jun 1;129(22):2980-2987. doi: 10.1182/blood-2016-08-731638. Epub 2017 Mar 29.

name: Duke Clinical Research Institute, Duke Health, Durham, NC;

name: Department of Neurology, Wake Forest School of Medicine, Winston Salem, NC;

name: University of California San Francisco, San Francisco, CA;

name: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden;

name: Brazilian Clinical Research Institute, Sao Paulo, Brazil; and

name: Department of Neurology and Headache Center, University of Duisburg-Essen, Essen, Germany

title: Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation therapy

ReferenceCitation: Cowper PA, Sheng S, Lopes RD, Anstrom KJ, Stafford JA, Davidson-Ray L, Al-Khatib SM, Ansell J, Dorian P, Husted S, McMurray JJV, Steg PG, Alexander JH, Wallentin L, Granger CB, Mark DB. Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective: Results From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):525-534. doi: 10.1001/jamacardio.2017.0065.

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

name: Department of Medicine, Hofstra Northwell School of Medicine, Hemstead, New York

name: Division of Cardiology, University of Toronto, Toronto, Ontario, Canada

name: British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland

name: Université Paris-Diderot, Sorbonne Paris Cité, French Alliance for Cardiovascular Clinical Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodeling, Assistance-Publique-Hôpitaux de Paris and Institut National de la Santé et de la Recherche Médicale U-1148, Paris, France7National Heart and Lung Institute, Royal Brompton Hospital, Imperial College, London, England

title: Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective

ReferenceCitation: Hu PT, Lopes RD, Stevens SR, Wallentin L, Thomas L, Alexander JH, Hanna M, Lewis BS, Verheugt FW, Granger CB, Jones WS. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease: Insights From the ARISTOTLE Trial. J Am Heart Assoc. 2017 Jan 17;6(1). pii: e004699. doi: 10.1161/JAHA.116.004699.

name: Department of Medicine, Duke University Medical Center, Durham, NC

name: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC

name: Lady Davis Carmel Medical Center, The Ruth and Bruce Rappaport School of Medicine of the Technion, Haifa, Israel

name: Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

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

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

title: Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease: Insights From the ARISTOTLE Trial

ReferenceCitation: Bahit MC, Lopes RD, Wojdyla DM, Held C, Hanna M, Vinereanu D, Hylek EM, Verheugt F, Goto S, Alexander JH, Wallentin L, Granger CB. Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation. Heart. 2017 Apr;103(8):623-628. doi: 10.1136/heartjnl-2016-309901. Epub 2016 Oct 24.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

title: Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation

ReferenceCitation: Oldgren J, Hijazi Z, Lindbäck J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Wallentin L; RE-LY and ARISTOTLE Investigators. Performance and Validation of a Novel Biomarker-Based Stroke Risk Score for Atrial Fibrillation. Circulation. 2016 Nov 29;134(22):1697-1707. Epub 2016 Aug 28.

ReferenceCitation: Alexander JH, Andersson U, Lopes RD, Hijazi Z, Hohnloser SH, Ezekowitz JA, Halvorsen S, Hanna M, Commerford P, Ruzyllo W, Huber K, Al-Khatib SM, Granger CB, Wallentin L; Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) Investigators. Apixaban 5 mg Twice Daily and Clinical Outcomes in Patients With Atrial Fibrillation and Advanced Age, Low Body Weight, or High Creatinine: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Sep 1;1(6):673-81. doi: 10.1001/jamacardio.2016.1829.

name: Duke Clinical Research Institute, Duke Health, Durham, North Carolina

name: Division of Clinical Electrophysiology, Goethe University, Frankfurt, Germany

name: Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada

name: Department of Cardiology, Oslo University Hospital and University of Oslo, Oslo, Norway

name: Bristol-Myers Squibb, Princeton, New Jersey

name: Department of Medicine, University of Cape Town, Cape Town, South Africa

name: Third Department of Medicine, Cardiology and Emergency Medicine, Wilhelminenspital, Vienna, Austria

name: for the Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) Investigators

title: Apixaban 5 mg Twice Daily and Clinical Outcomes in Patients With Atrial Fibrillation and Advanced Age, Low Body Weight, or High Creatinine

ReferenceCitation: Hijazi Z, Hohnloser SH, Andersson U, Alexander JH, Hanna M, Keltai M, Parkhomenko A, López-Sendón JL, Lopes RD, Siegbahn A, Granger CB, Wallentin L. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2016 Jul 1;1(4):451-60. doi: 10.1001/jamacardio.2016.1170.

name: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden2Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

name: J. W. Goethe University, Frankfurt, Germany

name: Duke Clinical Research Institute, Duke Medicine, Durham, North Carolina

name: Hungarian Institute of Cardiology, Semmelweis University, Budapest, Hungary

name: Hospital Universitario La Paz, IdiPaz, Madrid, Spain

name: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden9Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden

title: Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time

ReferenceCitation: Jaspers Focks J, Brouwer MA, Wojdyla DM, Thomas L, Lopes RD, Washam JB, Lanas F, Xavier D, Husted S, Wallentin L, Alexander JH, Granger CB, Verheugt FW. Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial. BMJ. 2016 Jun 15;353:i2868. doi: 10.1136/bmj.i2868.

title: Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial

ReferenceCitation: Hijazi Z, Oldgren J, Lindbäck J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4.

title: The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study

ReferenceCitation: Hijazi Z, Lindbäck J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.

title: The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation

ReferenceCitation: Hijazi Z, Aulin J, Andersson U, Alexander JH, Gersh B, Granger CB, Hanna M, Horowitz J, Hylek EM, Lopes RD, Siegbahn A, Wallentin L; ARISTOTLE Investigators. Biomarkers of inflammation and risk of cardiovascular events in anticoagulated patients with atrial fibrillation. Heart. 2016 Apr;102(7):508-17. doi: 10.1136/heartjnl-2015-308887. Epub 2016 Feb 2.

title: Biomarkers of inflammation and risk of cardiovascular events in anticoagulated patients with atrial fibrillation

ReferenceCitation: Rao MP, Halvorsen S, Wojdyla D, Thomas L, Alexander JH, Hylek EM, Hanna M, Bahit MC, Lopes RD, De Caterina R, Erol C, Goto S, Lanas F, Lewis BS, Husted S, Gersh BJ, Wallentin L, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Steering Committee and Investigators. Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. J Am Heart Assoc. 2015 Dec 1;4(12). pii: e002015. doi: 10.1161/JAHA.115.002015. Erratum in: J Am Heart Assoc. 2021 Feb 16;10(4):e014653.

name: Duke Clinical Research Institute Duke University Medical Center Durham NC

name: Boston University Medical Center Boston MA

name: INECO Neurociencias Oroño Rosario, Santa Fe Argentina

name: G. D'Annunzio Universita‐Chieti and Fondazione Toscana G. Monasterio Pisa Italy

name: Tokai University School of Medicine Isehara Japan

name: Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine Technion‐IIT Haifa Israel

name: Hospital UnitWest Herning/Holstbro Denmark

name: Mayo Clinic College of Medicine Rochester MN

name: the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Steering Committee and Investigators

title: Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial

ReferenceCitation: Vinereanu D, Stevens SR, Alexander JH, Al-Khatib SM, Avezum A, Bahit MC, Granger CB, Lopes RD, Halvorsen S, Hanna M, Husted S, Hylek EM, Mărgulescu AD, Wallentin L, Atar D. Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial. Eur Heart J. 2015 Dec 7;36(46):3268-75. doi: 10.1093/eurheartj/ehv447. Epub 2015 Sep 14.

title: Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial

ReferenceCitation: Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, Pais P, Erol C, Diaz R, Bahit MC, Bartunek J, De Caterina R, Goto S, Ruzyllo W, Zhu J, Granger CB, Alexander JH. Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. Circulation. 2015 Aug 25;132(8):624-32. doi: 10.1161/CIRCULATIONAHA.114.014807. Epub 2015 Jun 23.

name: From Research Division, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (A.A.); Duke Clinical Research Institute, Duke Medicine, Durham, NC (R.D.L., P.J.S., C.B.G., J.H.A.); Universidad de La Frontera, Temuco, Chile (F.L.); Mayo Clinic College of Medicine, Rochester, MN (B.J.G.); Bristol-Myers Squibb, Princeton, NJ (M.H.); St. John’s Medical College & Research Institute, Bangalore, India (P.P.); Ankara University School of Medicine, Turkey (C.E.); ECLA Estudios Cardiológicos...

title: Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease

ReferenceCitation: Held C, Hylek EM, Alexander JH, Hanna M, Lopes RD, Wojdyla DM, Thomas L, Al-Khalidi H, Alings M, Xavier D, Ansell J, Goto S, Ruzyllo W, Rosenqvist M, Verheugt FW, Zhu J, Granger CB, Wallentin L. Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial. Eur Heart J. 2015 May 21;36(20):1264-72. doi: 10.1093/eurheartj/ehu463. Epub 2014 Dec 12.

title: Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial

ReferenceCitation: Hijazi Z, Siegbahn A, Andersson U, Lindahl B, Granger CB, Alexander JH, Atar D, Gersh BJ, Hanna M, Harjola VP, Horowitz J, Husted S, Hylek EM, Lopes RD, McMurray JJ, Wallentin L. Comparison of cardiac troponins I and T measured with high-sensitivity methods for evaluation of prognosis in atrial fibrillation: an ARISTOTLE substudy. Clin Chem. 2015 Feb;61(2):368-78. doi: 10.1373/clinchem.2014.226936. Epub 2014 Dec 1.

name: Department of Medical Sciences, Cardiology, and

name: Duke University, Medical Center, Durham, NC

name: Department of Cardiology, Oslo University Hospital and Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway

name: University of Adelaide, Adelaide, Australia

name: Medical Department, Hospital Unit West, Herning/Holstbro, Denmark

name: BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, U.K

title: Comparison of Cardiac Troponins I and T Measured with High-Sensitivity Methods for Evaluation of Prognosis in Atrial Fibrillation: An ARISTOTLE Substudy

ReferenceCitation: Garcia D, Alexander JH, Wallentin L, Wojdyla DM, Thomas L, Hanna M, Al-Khatib SM, Dorian P, Ansell J, Commerford P, Flaker G, Lanas F, Vinereanu D, Xavier D, Hylek EM, Held C, Verheugt FW, Granger CB, Lopes RD. Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures. Blood. 2014 Dec 11;124(25):3692-8. doi: 10.1182/blood-2014-08-595496. Epub 2014 Oct 15.

name: Division of Hematology, University of Washington, Seattle, WA;

name: Duke Clinical Research Institute, Duke Medicine, Durham, NC;

name: Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden;

name: University of Toronto, Toronto, ON, Canada;

name: University of Cape Town, Cape Town, South Africa;

name: Universidad de La Frontera, Temuco, Chile;

name: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania;

name: St. John’s Medical College and Research Institute, Bangalore, India;

name: Boston University Medical Center, Boston, MA; and

name: Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

title: Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures

ReferenceCitation: Wallentin L, Hijazi Z, Andersson U, Alexander JH, De Caterina R, Hanna M, Horowitz JD, Hylek EM, Lopes RD, Asberg S, Granger CB, Siegbahn A; ARISTOTLE Investigators. Growth differentiation factor 15, a marker of oxidative stress and inflammation, for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Circulation. 2014 Nov 18;130(21):1847-58. doi: 10.1161/CIRCULATIONAHA.114.011204. Epub 2014 Oct 7.

name: From the Department of Medical Sciences, Cardiology (L.W., Z.H.), Department of Medical Sciences, Cardiovascular Epidemiology (S.A.), and Department of Medical Sciences, Clinical Chemistry (A.S.), and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W., Z.H.); Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (U.A.); Duke University, Medical Center, Durham, NC (J.H.A., R.D.L., C.B.G.); Gabriele d’Annunzio University, Chieti, and Gabriele Monasterio...

title: Growth Differentiation Factor 15, a Marker of Oxidative Stress and Inflammation, for Risk Assessment in Patients With Atrial Fibrillation

ReferenceCitation: Hijazi Z, Siegbahn A, Andersson U, Granger CB, Alexander JH, Atar D, Gersh BJ, Mohan P, Harjola VP, Horowitz J, Husted S, Hylek EM, Lopes RD, McMurray JJ, Wallentin L; ARISTOTLE Investigators. High-sensitivity troponin I for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Circulation. 2014 Feb 11;129(6):625-34. doi: 10.1161/CIRCULATIONAHA.113.006286. Epub 2013 Nov 13.

name: From the Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (Z.H., A.S., U.A., L.W.); Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden (Z.H., U.A., L.W.); Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden (A.S.); Duke University, Medical Center, Durham, NC (C.B.G., J.H.A., R.D.L.); Department of Cardiology, Oslo University Hospital and Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo...

title: High-Sensitivity Troponin I for Risk Assessment in Patients With Atrial Fibrillation

ReferenceCitation: Flaker G, Lopes RD, Al-Khatib SM, Hermosillo AG, Hohnloser SH, Tinga B, Zhu J, Mohan P, Garcia D, Bartunek J, Vinereanu D, Husted S, Harjola VP, Rosenqvist M, Alexander JH, Granger CB; ARISTOTLE Committees and Investigators. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation). J Am Coll Cardiol. 2014 Mar 25;63(11):1082-7. doi: 10.1016/j.jacc.2013.09.062. Epub 2013 Nov 6.

title: Efficacy and Safety of Apixaban in Patients After Cardioversion for Atrial Fibrillation

ReferenceCitation: Hijazi Z, Wallentin L, Siegbahn A, Andersson U, Alexander JH, Atar D, Gersh BJ, Hanna M, Harjola VP, Horowitz JD, Husted S, Hylek EM, Lopes RD, McMurray JJ, Granger CB; ARISTOTLE Investigators. High-sensitivity troponin T and risk stratification in patients with atrial fibrillation during treatment with apixaban or warfarin. J Am Coll Cardiol. 2014 Jan 7-14;63(1):52-61. doi: 10.1016/j.jacc.2013.07.093. Epub 2013 Sep 19.

repository_institution: Australian Catholic University - Research Bank

repositories_institution: Australian Catholic University - Research Bank

title: High-Sensitivity Troponin T and Risk Stratification in Patients With Atrial Fibrillation During Treatment With Apixaban or Warfarin

ReferenceCitation: Alexander JH, Levy E, Lawrence J, Hanna M, Waclawski AP, Wang J, Califf RM, Wallentin L, Granger CB. Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. Am Heart J. 2013 Sep;166(3):559-65. doi: 10.1016/j.ahj.2013.05.025. Epub 2013 Aug 15.

title: Documentation of study medication dispensing in a prospective large randomized clinical trial: Experiences from the ARISTOTLE Trial

ReferenceCitation: Garcia DA, Wallentin L, Lopes RD, Thomas L, Alexander JH, Hylek EM, Ansell J, Hanna M, Lanas F, Flaker G, Commerford P, Xavier D, Vinereanu D, Yang H, Granger CB. Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. Am Heart J. 2013 Sep;166(3):549-58. doi: 10.1016/j.ahj.2013.05.016. Epub 2013 Jul 25.

title: Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: Results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial

ReferenceCitation: Wallentin L, Lopes RD, Hanna M, Thomas L, Hellkamp A, Nepal S, Hylek EM, Al-Khatib SM, Alexander JH, Alings M, Amerena J, Ansell J, Aylward P, Bartunek J, Commerford P, De Caterina R, Erol C, Harjola VP, Held C, Horowitz JD, Huber K, Husted S, Keltai M, Lanas F, Lisheng L, McMurray JJ, Oh BH, Rosenqvist M, Ruzyllo W, Steg PG, Vinereanu D, Xavier D, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Investigators. Efficacy and safety of apixaban compared with warfarin at different levels of predicted international normalized ratio control for stroke prevention in atrial fibrillation. Circulation. 2013 Jun 4;127(22):2166-76. doi: 10.1161/CIRCULATIONAHA.112.142158. Epub 2013 May 2.

name: From the Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W., C.H.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L., L.T., A.H., S.M.A.-K., J.H.A., C.B.G.); Bristol-Myers Squibb, Princeton, NJ (M.H.); Novartis Pharmaceuticals, Florham Park, NJ (S.N.); Boston University Medical Center, Boston, MA (E.M.H.); Working Group on Cardiovascular Research the Netherlands, Utrecht, Netherlands (M.A.);...

title: Efficacy and Safety of Apixaban Compared With Warfarin at Different Levels of Predicted International Normalized Ratio Control for Stroke Prevention in Atrial Fibrillation

ReferenceCitation: McMurray JJ, Ezekowitz JA, Lewis BS, Gersh BJ, van Diepen S, Amerena J, Bartunek J, Commerford P, Oh BH, Harjola VP, Al-Khatib SM, Hanna M, Alexander JH, Lopes RD, Wojdyla DM, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators. Left ventricular systolic dysfunction, heart failure, and the risk of stroke and systemic embolism in patients with atrial fibrillation: insights from the ARISTOTLE trial. Circ Heart Fail. 2013 May;6(3):451-60. doi: 10.1161/CIRCHEARTFAILURE.112.000143. Epub 2013 Apr 10.

name: From the BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, United Kingdom (J.J.V.M.); Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada (J.A.E., S.v.D.); Department of Cardiovascular Medicine, Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.); Department of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, MN (B.J.G.); Geelong Cardiology Research Center, Deakin University, Burwood, VIC, Australia (J.A.);...

title: Left Ventricular Systolic Dysfunction, Heart Failure, and the Risk of Stroke and Systemic Embolism in Patients With Atrial Fibrillation

ReferenceCitation: Hijazi Z, Wallentin L, Siegbahn A, Andersson U, Christersson C, Ezekowitz J, Gersh BJ, Hanna M, Hohnloser S, Horowitz J, Huber K, Hylek EM, Lopes RD, McMurray JJ, Granger CB. N-terminal pro-B-type natriuretic peptide for risk assessment in patients with atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation). J Am Coll Cardiol. 2013 Jun 4;61(22):2274-84. doi: 10.1016/j.jacc.2012.11.082. Epub 2013 Apr 3.

title: N-Terminal Pro–B-Type Natriuretic Peptide for Risk Assessment in Patients With Atrial Fibrillation

ReferenceCitation: Lopes RD, Al-Khatib SM, Wallentin L, Yang H, Ansell J, Bahit MC, De Caterina R, Dorian P, Easton JD, Erol C, Ezekowitz JA, Gersh BJ, Granger CB, Hohnloser SH, Horowitz J, Hylek EM, McMurray JJ, Mohan P, Vinereanu D, Alexander JH. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet. 2012 Nov 17;380(9855):1749-58. doi: 10.1016/S0140-6736(12)60986-6. Epub 2012 Oct 2. Erratum in: Lancet. 2013 Jan 19;381(9862):204.

title: Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial

ReferenceCitation: Easton JD, Lopes RD, Bahit MC, Wojdyla DM, Granger CB, Wallentin L, Alings M, Goto S, Lewis BS, Rosenqvist M, Hanna M, Mohan P, Alexander JH, Diener HC; ARISTOTLE Committees and Investigators. Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of the ARISTOTLE trial. Lancet Neurol. 2012 Jun;11(6):503-11. doi: 10.1016/S1474-4422(12)70092-3. Epub 2012 May 8. Erratum in: Lancet Neurol. 2012 Dec;11(12):1021.

title: Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of the ARISTOTLE trial

ReferenceCitation: Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.

title: Apixaban versus Warfarin in Patients with Atrial Fibrillation

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location_facility: Family Practice Center Of Wadsworth, Inc.

location_facility: Arrhythmia Consultants Of The Central Coast Medical Group


ReferenceType: derived

ReferenceCitation: Pavel ME, Baudin E, Öberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193. Erratum in: Ann Oncol. 2019 Dec 1;30(12):2010.

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given: M.

family: Rouyrre

full_name: N. Rouyrre

given: N.

family: Peeters

full_name: M. Peeters

family: Gross

full_name: D.J. Gross

family: Yao

full_name: J.C. Yao

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

version: acceptedVersion

repositories:
PubMed Central
irua

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.

family: Fazio

full_name: Nicola Fazio

given: Nicola

family: Granberg

full_name: Dan Granberg

given: Dan

family: Grossman

full_name: Ashley Grossman

given: Ashley

family: Saletan

full_name: Stephen Saletan

given: Stephen

family: Klimovsky

full_name: Judith Klimovsky

given: Judith

family: Panneerselvam

full_name: Ashok Panneerselvam

given: Ashok

family: Wolin

full_name: Edward M. Wolin

given: Edward M.

journal_name: Chest

title: Everolimus Plus Octreotide Long-Acting Repeatable in Patients With Advanced Lung Neuroendocrine Tumors

ReferenceCitation: Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Öberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.

location_country:
Italy
United States
Sweden
United Kingdom
Netherlands
Germany
Finland
France
Greece
Slovakia
Belgium
Australia
Spain
Canada
Czech Republic

location_facility: University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)

location_facility: Duke University Medical Center Dept. of Duke Cancer Center

location_facility: Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)

location_facility: Texas Oncology, P.A. Forth Worth -- 12th Avenue

location_facility: Cancer Centers of Connecticut Southington Location

location_facility: Norton Cancer Institute Clinical Research Program

location_facility: South Texas Institute of Cancer S. Tex Inst.- Corpus Christi

location_facility: Central Indiana Cancer Centers CICC - South

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology

location_facility: University of Iowa Medical Center Internal Medicine

location_facility: Indiana University Dept.of IndianaUniv.CancerCtr

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: University of Kansas Cancer Center Deptof Uof Kansas CancerCenter

location_facility: Hematology Oncology PC Dept.of Hematology Oncology(2)

location_facility: Hematology Oncology Services of Arkansas

location_facility: New York University Medical Center NYU Medical Center (2)

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Highlands Oncology Group The Center for Chest Care

location_facility: University of California at Los Angeles UCLA New SC Address

location_facility: Kansas City Cancer Center KCCC Business Office

location_facility: Dartmouth Hitchcock Medical Center Medical Oncology

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center

location_facility: Virginia Oncology Associates VOA - Lake Wright

location_facility: Texas Oncology, P.A. Central Austin Cancer Center

location_facility: Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)

location_facility: Cancer Care and Hematology Specialists of Chicagoland Niles

location_facility: Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO

location_facility: Ocala Oncology Center Dept. of Ocala Oncology Center

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)

location_facility: Mayo Clinic - Rochester Division of Hematology

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

title: A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

summary: The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.


title: Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

acronym: LAPACT

summary: This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

family: Philip

full_name: Philip A Philip

given: Philip A

family: Lacy

full_name: Jill Lacy

given: Jill

family: Portales

full_name: Fabienne Portales

given: Fabienne

family: Sobrero

full_name: Alberto Sobrero

given: Alberto

family: Pazo-Cid

full_name: Roberto Pazo-Cid

given: Roberto

family: Manzano Mozo

full_name: José L Manzano Mozo

given: José L

family: Kim

full_name: Edward J Kim

given: Edward J

family: Dowden

full_name: Scot Dowden

given: Scot

family: Zakari

full_name: Ahmed Zakari

given: Ahmed

family: Borg

full_name: Christophe Borg

given: Christophe

family: Terrebonne

full_name: Eric Terrebonne

given: Eric

family: Rivera

full_name: Fernando Rivera

given: Fernando

family: Sastre

full_name: Javier Sastre

given: Javier

family: Bathini

full_name: Venu Bathini

given: Venu

family: López-Trabada

full_name: Daniel López-Trabada

given: Daniel

family: Asselah

full_name: Jamil Asselah

given: Jamil

family: Saif

full_name: Muhammad Wasif Saif

given: Muhammad Wasif

family: Shiansong Li

full_name: Jack Shiansong Li

given: Jack

family: Ong

full_name: Teng Jin Ong

given: Teng Jin

family: Nydam

full_name: Thomas Nydam

given: Thomas

family: Hammel

full_name: Pascal Hammel

given: Pascal

journal_name: The Lancet Gastroenterology & Hepatology

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Smilow Cancer Hospital At Yale-New Haven

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: State University of New York Upstate Medical Center

location_facility: Cancer Treatment Centers of America - Southeastern Regional Medical Center

location_facility: Karmanos Cancer Center Wayne State University

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Ospedale Sacro Cuore di Gesu FatebeneFratelli


ReferenceCitation: Cheng Y, He Y, Li W, Zhang HL, Zhou Q, Wang B, Liu C, Walding A, Saggese M, Huang X, Fan M, Wang J, Ramalingam SS. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021 Mar;16(2):165-176. doi: 10.1007/s11523-021-00794-6. Epub 2021 Feb 5.

family: Cheng

full_name: Ying Cheng

given: Ying

family: He

full_name: Yong He

given: Yong

family: Li

full_name: Wei Li

given: Wei

family: Zhang

full_name: He-long Zhang

given: He-long

family: Zhou

full_name: Qing Zhou

given: Qing

family: Wang

full_name: Buhai Wang

given: Buhai

family: Liu

full_name: Chunling Liu

given: Chunling

family: Walding

full_name: Andrew Walding

given: Andrew

family: Saggese

full_name: Matilde Saggese

given: Matilde

family: Huang

full_name: Xiangning Huang

given: Xiangning

family: Fan

full_name: Minhao Fan

given: Minhao

full_name: Jia Wang

given: Jia

family: Ramalingam

full_name: Suresh S. Ramalingam

given: Suresh S.

journal_name: Targeted Oncology

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Leighl NB, Karaseva N, Nakagawa K, Cho BC, Gray JE, Hovey T, Walding A, Rydén A, Novello S. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020 Jan;125:49-57. doi: 10.1016/j.ejca.2019.11.006. Epub 2019 Dec 12.

family: Leighl

full_name: Natasha B. Leighl

given: Natasha B.

family: Karaseva

full_name: Nina Karaseva

given: Nina

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Cho

full_name: Byoung-Chul Cho

given: Byoung-Chul

family: Gray

full_name: Jhanelle E. Gray

given: Jhanelle E.

family: Hovey

full_name: Tina Hovey

given: Tina

repository_institution: Yonsei University Medical Library - YUHSpace

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21.

name: From Winship Cancer Institute, Emory University School of Medicine, Atlanta (S.S.R.); the Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospital KU Leuven, Leuven, Belgium (J.V.); the Thoracic Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif (D.P., J.-C.S.), and University Paris Sud, Orsay (J.-C.S.) — both in France; the Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C...

ReferenceCitation: Brown H, Vansteenkiste J, Nakagawa K, Cobo M, John T, Barker C, Kohlmann A, Todd A, Saggese M, Chmielecki J, Markovets A, Scott M, Ramalingam SS. Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA. J Thorac Oncol. 2020 Jan;15(1):138-143. doi: 10.1016/j.jtho.2019.09.009. Epub 2019 Oct 9.

ReferenceCitation: Gray JE, Okamoto I, Sriuranpong V, Vansteenkiste J, Imamura F, Lee JS, Pang YK, Cobo M, Kasahara K, Cheng Y, Nogami N, Cho EK, Su WC, Zhang G, Huang X, Li-Sucholeiki X, Lentrichia B, Dearden S, Jenkins S, Saggese M, Rukazenkov Y, Ramalingam SS. Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Nov 15;25(22):6644-6652. doi: 10.1158/1078-0432.CCR-19-1126. Epub 2019 Aug 22.

publisher: American Association for Cancer Research (AACR)

title: Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non–Small Cell Lung Cancer

ReferenceCitation: Planchard D, Boyer MJ, Lee JS, Dechaphunkul A, Cheema PK, Takahashi T, Gray JE, Tiseo M, Ramalingam SS, Todd A, McKeown A, Rukazenkov Y, Ohe Y. Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2058-2063. doi: 10.1158/1078-0432.CCR-18-3325. Epub 2019 Jan 18.

title: Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non–Small Cell Lung Cancer

ReferenceCitation: Ohe Y, Imamura F, Nogami N, Okamoto I, Kurata T, Kato T, Sugawara S, Ramalingam SS, Uchida H, Hodge R, Vowler SL, Walding A, Nakagawa K. Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset. Jpn J Clin Oncol. 2019 Jan 1;49(1):29-36. doi: 10.1093/jjco/hyy179.

name: Department of Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

name: Department of Thoracic Oncology, Osaka International Cancer Institute, Chuo-ku, Osaka, Japan

name: Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Minamiumemoto-machi, Matsuyama, Japan

name: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Japan

name: Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Osaka, Japan

name: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanazawa-ku, Yokohama, Japan

name: Department of Pulmonary Medicine, Sendai Kousei Hospital, Aoba-ku, Sendai, Japan

name: Winship Cancer Institute, Emory University, Atlanta, GA, USA

name: Research and Development, AstraZeneca K.K., Grand Front Osaka Tower B, Kita-ku, Osaka, Japan

name: AstraZeneca, Cambridge, da Vinci Building, Melbourn Science Park, Melbourn, Cambridgeshire, UK

name: Department of Medical Oncology, Kindai University Hospital, Ohno-higashi, Osaka, Japan

ReferenceCitation: Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.

name: From Gustave Roussy Cancer Campus and University Paris-Sud, Orsay, France (J.-C.S., D.P.); the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo (Y.O.), the Department of Thoracic Oncology, Osaka International Cancer Institute (F.I.), and the Department of Thoracic Oncology, Kansai Medical University Hospital (T.K.), Osaka, the Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama (N.N.), and the Research Institute for Diseases of the Chest...

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Osimertinib in UntreatedEGFR-Mutated Advanced Non–Small-Cell Lung Cancer

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:
Malaysia
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Sweden
Switzerland
Vietnam
Philippines
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
Spain
Turkey

title: A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

summary: To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer


title: A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.

summary: To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C

design_allocation: Randomized

lead_sponsor: Solvay Pharmaceuticals

location_country:
India
France
Poland
Lithuania
Slovakia
Hungary
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia

summary: Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.

status: Terminated

enrollment_type: Anticipated

location_country: Netherlands Finland Croatia France Poland Romania Germany Ukraine

location_facility:
Site 411
Site 303
Site 410
Site 408
Site 505
Site 603
Site 701
Site 705
Site 407
Site 809
Site100
Site 301
Site 805
Site101
Site 802
Site 402
Site 606
Site 305
Site 807
Site 612
Site 306
Site 403
Site 409
Site 810
Site 208
Site 406
Site 205
Site 604
Site 607
Site 602
Site 400
Site 808
Site 509
Site102
Site 608
Site 302
Site 207
Site 304
Site 412
Site 605
Site 502
Site 405
Site 800
Site 700
Site 413
Site105
Site 206
Site 613
Site 508
Site 803
Site 702
Site 804
Site 506
Site 307
Site 703
Site 600
Site 401
Site 500
Site 503
Site 610
Site 811
Site 704
Site 812
Site 813
Site103
Site 601
Site 507
Site 404
Site 504
Site104

status_simplified: Unknown


title: A Phase II, Open-Label, Randomized, Multicenter Trial of GW786034 (Pazopanib) in Combination With Lapatinib (GW572016) Compared to Lapatinib Alone as First Line Therapy in Subjects With Advanced or Metastatic Breast Cancer With ErbB2 Fluorescence In Situ Hybridization (FISH) Positive Tumors

summary: This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

ReferenceType: background

ReferenceCitation: Johnston SR, Gómez H, Stemmer SM, Richie M, Durante M, Pandite L, Goodman V, Slamon D. A randomized and open-label trial evaluating the addition of pazopanib to lapatinib as first-line therapy in patients with HER2-positive advanced breast cancer. Breast Cancer Res Treat. 2013 Feb;137(3):755-66. doi: 10.1007/s10549-012-2399-4. Epub 2013 Jan 3.

ReferenceCitation: de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

family: de Jonge

full_name: Maja J. A. de Jonge

given: Maja J. A.

family: Hamberg

full_name: Paul Hamberg

given: Paul

family: Verweij

full_name: Jaap Verweij

given: Jaap

family: Savage

full_name: Shawna Savage

given: Shawna

family: Suttle

full_name: A. Benjamin Suttle

given: A. Benjamin

family: Hodge

full_name: Jeffrey Hodge

given: Jeffrey

family: Arumugham

full_name: Thangam Arumugham

given: Thangam

family: Pandite

full_name: Lini N. Pandite

given: Lini N.

family: Hurwitz

full_name: Herbert I. Hurwitz

given: Herbert I.

journal_name: Investigational New Drugs

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: GlaxoSmithKline

location_country:
Peru
India
Mexico
Pakistan
France
Korea, Republic of
Malaysia
Israel
Poland
Singapore
Hungary
Russian Federation
Thailand
United States
United Kingdom
Canada


title: A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).

acronym: PERSPECTIVES

summary: The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

design_allocation: Non-Randomized

ReferenceCitation: Chakravarthy U, Staurenghi G, Kwok K, Tressler CS, Buggage R; PERSPECTIVES Study Group. Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: findings of the PERSPECTIVES study. Br J Ophthalmol. 2012 Oct;96(10):1351-4. Epub 2012 Aug 7.

lead_sponsor: Pfizer

location_country:
Italy
Austria
United Kingdom
Spain
Germany
Finland
France
Poland
Greece
Belgium
Portugal
Turkey
Denmark
Canada
Czech Republic


title: A Phase III, Open-Label, Prospective, Two-Armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study Regimen Versus Observation in Patients With Diffuse Large B-Cell Lymphoma Who Are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy

summary: This study will treat patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with CHOP-R. Half of the patients will receive Zevalin and the other half will receive no further anti-cancer treatment. The two patient groups will be compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP R.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: CTI BioPharma

location_country:
Italy
Austria
United States
Sweden
Switzerland
Spain
Germany
Finland
France
Poland
Thailand
Singapore
Hungary
Belgium
Ireland
Portugal
Canada
United Kingdom
Korea, Republic of

intervention_type: Other


title: A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma

summary: The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

ReferenceCitation: Zinzani PL, Khuageva NK, Wang H, Garicochea B, Walewski J, Van Hoof A, Soubeyran P, Caballero D, Buckstein R, Esseltine DL, Theocharous P, Enny C, Zhu E, Elsayed YA, Coiffier B. Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naïve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial. J Hematol Oncol. 2012 Oct 22;5:67. doi: 10.1186/1756-8722-5-67.

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Khuageva

full_name: Nuriet K Khuageva

given: Nuriet K

family: Wang

full_name: Huaqing Wang

given: Huaqing

family: Garicochea

full_name: Bernardo Garicochea

given: Bernardo

family: Walewski

full_name: Jan Walewski

given: Jan

family: Van Hoof

full_name: Achiel Van Hoof

given: Achiel

family: Soubeyran

full_name: Pierre Soubeyran

given: Pierre

family: Caballero

full_name: Dolores Caballero

given: Dolores

family: Buckstein

full_name: Rena Buckstein

given: Rena

family: Esseltine

full_name: Dixie-Lee Esseltine

given: Dixie-Lee

family: Theocharous

full_name: Panteli Theocharous

given: Panteli

family: Enny

full_name: Christopher Enny

given: Christopher

family: Zhu

full_name: Eugene Zhu

given: Eugene

family: Elsayed

full_name: Yusri A Elsayed

given: Yusri A

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

currency_apc_doaj: GBP

journal_name: Journal of Hematology & Oncology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

ReferenceCitation: Coiffier B, Osmanov EA, Hong X, Scheliga A, Mayer J, Offner F, Rule S, Teixeira A, Walewski J, de Vos S, Crump M, Shpilberg O, Esseltine DL, Zhu E, Enny C, Theocharous P, van de Velde H, Elsayed YA, Zinzani PL; LYM-3001 study investigators. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. Lancet Oncol. 2011 Aug;12(8):773-84. doi: 10.1016/S1470-2045(11)70150-4. Epub 2011 Jul 1.

location_country:
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Czech Republic
Ukraine
India
France
Poland
Thailand
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Cyprus
Israel
New Zealand
Spain

location_facility: East Cape Oncology Centre - St. Georges Hospital

location_facility: Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE

location_facility: Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine

location_facility: UZ Antwerpen - Universitair Ziekenhuis Antwerpen

location_facility: Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Institutul Clinic Fundeni Clinica de Hematologie

location_facility: Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra

location_facility: Samsung Medical Center - Department of Internal Medicine

location_facility: 1st Republican Clinical Hospital of Udmurtia

location_facility: Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Spitalul Clinic judetean de urgenta Mures

location_facility: Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran

location_facility: Aberdeen Royal Infirmary - Department of Haematology

location_facility: University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute

location_facility: Wojskowy Instytut Medyczny - Klinika Hematologii

location_facility: Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.

location_facility: Republikan Hospital named after V.A. Baranov

location_facility: FN F.D. Roosevelt - Oddelenie hematologie

location_facility: Dnepropetrovsk Regional Clinical Oncology Dispensary

location_facility: University Health Network - Princess Margaret Hospital

location_facility: Hospital Germans Trias i Pujol Institut Catala d'Oncologia

location_facility: Martinska FN, Klinika hematologie a transfuziologie

location_facility: Centrum for Hematologi Karolinska University Hospital

location_facility: Crimean Republic Clinical Oncology Dispensary

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Azienda Ospedallera Universitaria Policlinico Tor Vergata

location_facility: Klinika Hematologii Instytut Chorob Wewnetrznych

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary

location_facility: Service des Maladies due sang - Hopital haut Leveque

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Central Hematology Oncology Medical Group, Inc

location_facility: Saint Petersburg Pavlov State Medical University

location_facility: Klinika Hematologii - Uniwersytetu Medycznego

location_facility: Zhitomir Gerbachevsky Regional Clinical Hospital

location_facility: SZEgedi Tudomanyegyetem, II Belgyaszati Klinika

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL

location_facility: Innovative Clinical Research of South Florida

location_facility: Cheliabinsk Regional Oncology Dispensary

location_facility: Emory Univeersity ,Winship Cancer Institute

location_facility: University Hospital of Patras - Department of Internal Medicine - Hematology Division

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Affiliated Hospital of the Academy of Military Medical Sciences

location_facility: Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie

location_facility: Apollo Hospitals, Hyderabad Apollo Hospital Complex

location_facility: Instituto Nacional De Cancerologia Incan

location_facility: Virga Jesse Ziekenhuis, Dienst Hematologie

location_facility: Derriford Hospital - Department of Haematology

location_facility: Department of Medical Oncology - Regional Cancer Centre

location_facility: Hematologiska kliniken M54 Karolinska University Hospital

location_facility: Hospital Durans I Reynals - Institut Catala d'Oncologia

location_facility: Investigative Clinical Research of Indiana

location_facility: Lung Cancer Center - National Cancer Center

location_facility: Spitalul Universitar de Urgenta Hematologie

location_facility: Addenbrooke's Hospital - Department of Haematology

location_facility: The Center for Cancer and Blood Disorders

location_facility: Vychodoslovensky Onkologicky Ustave, a.s.

location_facility: Azienda Ospedaliero Universitaria di Bologna

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5

location_facility: Moscow Region Clinical Research Institute

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Republican Clinical Hospital of Bashkorkostan

location_facility: St. Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie

location_facility: Klinika Hematologii i Transplantologii Szpiku AM

location_facility: Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Central Coast Medical Oncology Corporation

location_facility: Universitatsklinikum Munster - Klinik fur Innere Medizin

location_facility: University of California, Irvine Medical Center

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

location_facility: Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine

location_facility: Mary Potter Oncology Centre - Little Company of Mary Hospital


ReferenceCitation: Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.

family: Heier

full_name: Jeffrey S. Heier

given: Jeffrey S.

family: Pieramici

full_name: Dante Pieramici

given: Dante

family: Chakravarthy

full_name: Usha Chakravarthy

given: Usha

family: Patel

full_name: Sunil S. Patel

given: Sunil S.

family: Gupta

full_name: Sunil Gupta

given: Sunil

family: Lotery

full_name: Andrew Lotery

given: Andrew

family: Lad

full_name: Eleonora M. Lad

given: Eleonora M.

family: Silverman

full_name: David Silverman

given: David

family: Henry

full_name: Erin C. Henry

given: Erin C.

family: Anderesi

full_name: Majid Anderesi

given: Majid

family: Tschosik

full_name: Elizabeth A. Tschosik

given: Elizabeth A.

family: Gray

full_name: Sarah Gray

given: Sarah

family: Ferrara

full_name: Daniela Ferrara

given: Daniela

family: Guymer

full_name: Robyn Guymer

given: Robyn

journal_name: Ophthalmology Retina

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.

name: Department of Ophthalmology, University of Bonn, Bonn, Germany

family: Holz

full_name: Frank G. Holz

given: Frank G.

name: Doheny Eye Institute, Los Angeles, California

name: Department of Ophthalmology, University of California at Los Angeles

family: Sadda

full_name: Srinivas R. Sadda

given: Srinivas R.

family: Busbee

full_name: Brandon Busbee

given: Brandon

name: Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland

family: Chew

full_name: Emily Y. Chew

given: Emily Y.

name: Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Sydney, Australia

family: Mitchell

full_name: Paul Mitchell

given: Paul

name: Moorfields Eye Hospital, London, United Kingdom

family: Tufail

full_name: Adnan Tufail

given: Adnan

name: Genentech Inc, a Member of the Roche Group, South San Francisco, California

family: Brittain

full_name: Christopher Brittain

name: Johns Hopkins University School of Medicine, Baltimore, Maryland

name: for the Chroma and Spectri Study Investigators

location_country:
Peru
Australia
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Argentina
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Spain
Turkey

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Dokuz Eylul University Medical Faculty; Department of Ophthalmology

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

location_facility: FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

location_facility: A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: University of California, Davis, Eye Center

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Instituto Mexicano de Oftalmologia I.A.P.

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: Retina & Vitreous Center of Southern Oregon

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: University of Michigan, Kellogg Eye Center

location_facility: Inselspital Bern, Universitätsklinik für Augenheilkunde

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Hospital Perpetuo Socorro; Servicio de Oftalmología

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

location_facility: Hospital Universitario la Fe: Servicio de Oftalmologia

location_facility: SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Macular Treatment Centre; Royal Eye Hospital

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Istanbul University Istanbul Medical Faculty; Department of Ophthalmology

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Centre Paradis Monticelli; Ophtalmologie

title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).