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. |
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| Results expected: | in 2009 |
| Clinical outcome: | Primary outcomes:
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| 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. |
17 January 2008Boehringer Ingelheim announces enrolment completion of the largest atrial fibrillation outcomes trial - The RE-LY™ Study
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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.
