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news.Boehringer Ingelheim has completed enrollment for the landmark RE-LY trial to evaluate the long-term efficacy and safety of investigational oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
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The RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) trial is a global, multi-center, non-inferiority, randomized trial comparing two blinded doses (150mg twice daily or 110mg twice daily) of dabigatran etexilate with open label warfarin sodium in patients with non-valvular atrial fibrillation and at least one other major risk factor for stroke. The median treatment duration is anticipated to be two years. Currently, more than 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.
Primary outcomes of the trial will measure the incidence of stroke (including hemorrhagic) and systemic embolism. Secondary outcome measures include all death, incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding).