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Research

Photo for RE-LY

RE-LY

Official Title

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy & Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke & Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

Status

Completed

Overview

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

Randomized, parallel group design, non-inferiority, prospective multicenter trial.

Primary Endpoint

Incidence of stroke (including hemorrhagic) and systemic embolism. Secondary Endpoint: Incidence of stroke (including hemorrhagic), systemic embolism, all death; Incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding). All primary and secondary events are adjudicated.

Number of Patients

18113

Number of Sites

951

Number of Countries

44

Study Period

2005–2009

Principal Investigator

Stuart Connolly, Michael Ezekowitz

Program Manager

Ellison Themeles

Research Coordinator

Gayle Lewis, Kim Simek, Alex Grinvalds, Mary Micks, Suzanne Bajkor

Collaborators

Boehringer-Ingelheim

Key Publications

  • 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.
  • 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.
  • 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.