Population Health Research Institute
Study List

RE-LY (Completed) 
Randomized Evaluation of Long Term Anticoagulant TherapY

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 The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

Study Design: Parallel Assignment, Safety/Efficacy Study

Intervention: Dabigatran etexilate vs. Warfarin

Length of Study: 6 years

# of Patients: 18,000

Patient Populations: Atrial fibrillation.


Presentations

Not available at this time.


Main Publications (for a full listing of publications, please visit the 'Media and Publications' section)

Paul A. Reilly, PHD, Thorsten Lehr, PHD, Sebastian Haertter, PHD, Stuart J. Connolly, MD, Salim Yusuf, MD, DPHIL, John W. Eikelboom, MB BS, Michael D. Ezekowitz, MD, PHD, Gerhard Nehmiz, PHD, Susan Wang, PHD, Lars Wallentin, MD, PHD, on behalf of the RE-LY Investigators. The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients: The RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol. 2014; 63(4): 321-328.

Ziad Hijazi, Stefan H. Hohnloser, Jonas Oldgren, Ulrika Andersson, Stuart J. Connolly, John W. Eikelboom, Michael D. Ezekowitz, Paul A. Reilly, Agneta Siegbahn, Salim Yusuf and Lars Wallentin. Efficacy and Safety of Dabigatran Compared with Warfarin in Relation to Baseline Renal Function in Patients with Atrial Fibrillation: A RE-LY Trial Analysis. Circulation 2013; Dec 9 (published online before print).

Paolo Verdecchia, MD, Gianpaolo Reboldi, MD, PhD, Giuseppe Di Pasquale, MD, Giovanni Mazzotta, MD, Giuseppe Ambrosio, MD, Sean Yang, PhD, Janice Pogue, PhD, Lars Wallentin, MD, Michael D. Ezekowitz, MD, Stuart J. Connolly, MD, and Salim Yusuf, MD, On behalf of the RE-LY Study Investigators. Prognostic Usefulness of Left Ventricular Hypertrophy by Electrocardiography in Patients With Atrial Fibrillation (from the Randomized Evaluation of Long-Term Anticoagulant Therapy Study). American Journal of Cardiology 2013; Nov 25 (published online before print).

Ammar Majeed, Hun-Gyu Hwang, Stuart J. Connolly, John W. Eikelboom, Michael D. Ezekowitz, Lars Wallentin, Martina Brueckmann, Mandy Fraessdorf, Salim Yusuf and Sam Schulman. Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin. Circulation 2013; Sept 30 (published online before print).

Eloi Marijon, Jean-Yves Le Heuzey, Stuart Connolly, Sean Yang, Janice Pogue, Martina Brueckmann, John W. Eikelboom, Ellison Themeles, Michael D. Ezekowitz, Lars Wallentin and Salim Yusuf. Causes of Death and Influencing Factors in Patients with Atrial Fibrillation: A Competing Risk Analysis from the Randomized Evaluation of Long-Term Anticoagulant Therapy Study. Circulation 2013; Sept 09 (Published online before print).
John W. Eikelboom, MBBS; Stuart J. Connolly, MD; Robert G. Hart, MD; Lars Wallentin, MD, PhD; Paul Reilly, PhD; Jonas Oldgren, MD, PhD; Sean Yang, MSc; Salim Yusuf, MD, DPhil. Balancing the Benefits and Risks of 2 Doses of Dabigatran Compared With Warfarin in Atrial Fibrillation. J Am Coll Cardiol. 2013; 62(10): 900-908 (Published online June 14).
Jorge Ferreira, Michael D. Ezekowitz, Stuart J. Connolly, Martina Brueckmann, Mandy Fraessdorf, Paul A. Reilly, Salim Yusuf, and Lars Wallentin on behalf of the RE-LY Investigators. Dabigatran compared with warfarin in patients with atrial fibrillation and symptomatic heart failure: a subgroup analysis of the RE-LY trial. Eur J Heart Fail 2013; 15 (9): 1053-1061. (First published online July 9, 2013).
Masatsugu Hori, Stuart J. Connolly, Jun Zhu, Li Sheng Liu, Chu-Pak Lau, Prem Pais, Denis Xavier, Sung Soon Kim, Razali Omar, Antonio L. Dans, Ru San Tan, Jyh-Hong Chen, Supachai Tanomsup, Mitsunori Watanabe, Masahide Koyanagi, Michael D. Ezekowitz, Paul A. Reilly, Lars Wallentin and Salim Yusuf. Dabigatran Versus Warfarin : Effects on Ischemic and Hemorrhagic Strokes and Bleeding in Asians and Non-Asians With Atrial Fibrillation. Stroke 2013; June 6 (Published online).
Guillaume Paré, Niclas Eriksson, Thorsten Lehr, Stuart Connolly, John Eikelboom, Michael D. Ezekowitz, Tomas Axelsson, Sebastian Haertter, Jonas Oldgren, Paul Reilly, Agneta Siegbahn, Ann-Christine Syvanen, Claes Wadelius, Mia Wadelius, Heike Zimdahl-Gelling, Salim Yusuf, and Lars Wallentin. Genetic Determinants of Dabigatran Plasma Levels and Their Relation to Bleeding. Circulation 2013; 127: 1404-1412. (Published online before print March 6).
Antonio L. Dans, Stuart J. Connolly, Lars Wallentin, Sean Yang, Juliet Nakamya, Martina Brueckmann, Michael Ezekowitz, Jonas Oldgren, John W. Eikelboom, Paul A. Reilly and Salim Yusuf. Concomitant Use of Antiplatelet Therapy with Dabigatran or Warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY®) Trial. Circulation 2012; December 27 (Published online).
Peter Bytzer, Stuart J. Connolly, Sean Yang, Michael Ezekowitz, Stephan Formella, Paul A. Reilly,  James Aisenberg. Analysis of Upper Gastrointestinal Adverse Events Among Patients Given Dabigatran in the RE-LY Trial. Clinical Gastroenterology and Hepatology 2012; Oct 26 (Published online)

Harriette G.C. Van Spall, Lars Wallentin, Salim Yusuf, John W. Eikelboom, Robby Nieuwlaat, Sean Yang, Conrad Kabali, Paul A. Reilly, Michael D. Ezekowitz, Stuart J. Connolly. Variation in Warfarin Dose Adjustment Practice Is Responsible for Differences in the Quality of Anticoagulation Control Between Centers and Countries. An Analysis of Patients Receiving Warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Trial. Circulation 2012; 126: 2309-2316. (Oct 1, 2012 Published online before print).

Jeff S. Healey, John Eikelboom, James Douketis, Lars Wallentin, Jonas Oldgren, Sean Yang, Ellison Themeles, Hein Heidbuchel, Alvaro Avezum, Paul Reilly, Stuart J. Connolly, Salim Yusuf and Michael Ezekowitz. Peri-Procedural Bleeding and Thromboembolic Events with Dabigatran Compared to Warfarin: Results from the RE-LY Randomized Trial. Circulation 2012; June 14 (Published Online).

Robert G. Hart, Hans-Christoph Diener, Sean Yang, Stuart J. Connolly, Lars Wallentin, Paul A. Reilly, Michael D. Ezekowitz and Salim Yusuf. Intracranial Hemorrhage in Atrial Fibrillation Patients During Anticoagulation With Warfarin or Dabigatran: The RE-LY Trial. Stroke 2012; April 5 (Published Online).

Ziad Hijazi, Jonas Oldgren, Ulrika Andersson, Stuart J. Connolly, Michael D. Ezekowitz, Stefan H. Hohnloser, Paul A. Reilly, Dragos Vinereanu, Agneta Siegbahn, Salim Yusuf and Lars Wallentin. Cardiac Biomarkers are Associated with an Increased Risk of Stroke and Death in Patients with Atrial Fibrillation: A RELY Substudy. Circulation 2012; Feb 28 (Published Online).
Stefan H. Hohnloser, Jonas Oldgren, Sean Yang, Lars Wallentin, Michael Ezekowitz, Paul Reilly, John Eikelboom, Martina Brueckmann, Salim Yusuf and Stuart J. Connolly. Myocardial Ischemic Events in Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin in the RE-LY Trial. Circulation 2012; Jan 3 (Published Online).
Greg Flaker, Michael Ezekowitz, Salim Yusuf, Lars Wallentin, Herbert Noack, Martina Brueckmann, Paul Reilly, Stefan H. Hohnloser, and Stuart Connolly. Efficacy and Safety of Dabigatran Compared to Warfarin in Patients With Paroxysmal, Persistent, and Permanent Atrial Fibrillation: Results From the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Study. J. Am. Coll. Cardiol. 2012; 59; 854-855.
Thorsten Lehr, Sebastian Haertter, Karl-Heinz Liesenfeld, Alexander Staab, Andreas Clemens, Paul A. Reilly, Jeffrey Friedman. Dabigatran Etexilate in Atrial Fibrillation Patients with Severe Renal Impairment: Dose Identification Using Pharmacokinetic Modeling and Simulation. The Journal of Clinical Pharmacology 2011; Sept 28 (published online).

Nagarakanti R, Ezekowitz MD, Oldgren J, Yang S, Chernick M, Aikens TH, Flaker G, Brugada J, Kamensky G, Parekh A, Reilly PA, Yusuf S, Connolly SJ. Dabigatran Versus Warfarin in Patients With Atrial Fibrillation: An Analysis of Patients Undergoing Cardioversion. Circulation 2011; 123: 131 - 136. **

** Received Circulation's Best Paper Award, Clinical Science (May 2, 2011)

Sorensen SV, Kansal AR, Connolly S, Peng S, Linnehan J, Bradley-Kennedy C, Plumb J. Cost-effectiveness of Dabigatran etexilate for the Prevention of Stroke and Systemic Embolism in Atrial Fibrillation: A Canadian payer perspective. Thrombosis & Haemostasis 2011; Mar 22 (Prepublished Online).

Hori M, Connolly S, Ezekowitz M, Reilly PA, Yusuf S, Wallentin L, RE-LY Investigators. Efficacy and Safety of Dabigatran vs. Warfarin in Patients With Atrial Fibrillation - Sub-Analysis in Japanese Population in RE-LY Trial. Circulation Journal 2011; Mar 19 (Advance Publication Online).

Jonas Oldgren, Marco Alings, Harald Darius, Hans-Christoph Diener, John Eikelboom, Michael D. Ezekowitz, Gabriel Kamensky, Paul A. Reilly, Sean Yang, Salim Yusuf, Lars Wallentin, Stuart J. Connolly, on behalf of the RE-LY Investigators. Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS2 Score: A Subgroup Analysis of the RE-LY Trial. Ann Intern Med. 2011; 155: 660-667.
John W. Eikelboom, Lars Wallentin, Stuart J. Connolly, Mike Ezekowitz, Jeff S. Healey, Jonas Oldgren, Sean Yang, Marco Alings, Scott Kaatz, Stefan H. Hohnloser, Hans-Christoph Diener, Maria Grazia Franzosi, Kurt Huber, Paul Reilly, Jeanne Varrone, Salim Yusuf. Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation. Circulation 2011; 123: 2363-2372.
Liesenfeld K-H, Lehr T, Dansirikul C, Reilly PA, Connolly SJ, Ezekowitz MD, Yusuf S, Wallentin L, Haertter S, Staab A. Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial. J Thromb Haemost 2011; 9: 2168-75.

Ezekowitz MD, Wallentin L, Connolly SJ, Parekh A, Chernick MR, Pogue J, Aikens TH, Yang S, Reilly PA, Lip GYH, Yusuf S, RE-LY Steering Committee, RE-LY Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation 2010; 122 (22): 2246 - 2253.

Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L, Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly Identified Events in the RE-LY Trial. N Engl J Med 2010; 363 (19): 1875 - 1877.
Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, Pais P, Dans A, Eikelboom J, Oldgren J, Pogue J, Reilly PA, Yang S, Connolly SJ, RE-LY Investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010; 376: 975 - 983.
Diener HC, Connolly SJ, Ezekowitz MD, Wallentin L, Reilly PA, Yang S, Xavier D, Di Pasquale G, Yusuf S, RE-LY Study Group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol 2010; 9: 1157 - 1163.
Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J 2009; 157 (5): 805 - 810.
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L, RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361 (12): 1139 - 1151.
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