Landmark Trials

RE-LY™ (Randomized Evaluation of Long Term Anticoagulant Therapy) is a global, multi-centre, non-inferiority, randomised trial comparing two blinded doses of dabigatran etexilate with open label warfarin in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

RE-LY™ Overview

Duration: The median treatment duration is two years with a minimum of 1 year follow-up.
Results expected: in 2009
Clinical outcome: Primary outcomes:
  • Efficacy: Composite of stroke (including hemorrhagic) and systemic embolism
  • Safety: Bleeding events during treatment
Study design: Prospective, multi-centre, randomized, open-label, controlled parallel group, non-inferiority trial.
Lead investigator: The trial is led by

Dr Salim Yusuf, Professor of Epidemiology and Cardiology, Population Health Research Institute McMaster University, Hamilton, Canada;

Dr Lars Wallentin, Professor of Cardiology and Director of the Uppsala University, Sweden;

Dr Michael Ezekowitz, Vice President and Professor, Lankenau Institute for Medical Research, Wynnewood, PA, USA;

Dr Stuart Connolly, Professor of Medicine and Director, Division of Cardiology at McMaster University, Hamilton, Canada.

The phase III - study of stroke prevention in atrial fibrillation, called RE-LY™ is under the umbrella of the so-called RE-VOLUTION™ trial programme.

The RE-LY™ trial is comparing two blinded doses of oral dabigatran etexilate with the current standard therapy, warfarin (target INR 2.0-3.0) in patients with non-valvular atrial fibrillation who are at moderate to high risk of stroke.

Rely Worldwide