The design of the RE-ALIGN study, the first study to evaluate a novel oral anticoagulant as alternative to warfarin for use in patients with mechanical heart valves requiring anticoagulation therapy, has been published recently by the American Heart Journal.1
The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGigatran etexilate in patients after heart valve replacemeNt (RE-ALIGN), addresses current limitations experienced with warfarin and is designed to identify a safe and effective dosing regimen of dabigatran (Pradaxa® , Boehringer-Ingelheim) for the prevention of valve thrombosis, stroke and systemic embolism in this patient population, prior to further investigation in a larger phase III study.
The study evaluated dabigatran in patients with mechanical bi-leaflet heart valve during a follow-up period of 12 weeks. Based on the results, a sufficiently powered phase III study is planned to investigate efficacy outcomes for dabigatran in this patient population.
The different dosing regimens that are under investigation for dabigatran in RE-ALIGN are 150 mg bid, 220 mg bid, and 300 mg bid, with the starting dose determined by the individual patient’s creatinine clearance. The study includes patients with recent surgery for implantation of mechanical bileaflet heart valve who have not yet started oral anticoagulation, and patients who had surgery at least three months before randomisation and are currently taking an oral vitamin K antagonist.
Patients are randomised to receive either dabigatran or the vitamin K antagonist warfarin. After the 12 week study period, patients are given the opportunity to opt-in to continue treatment with dabigatran within the RE-ALIGN extension trial, allowing investigators to collect long-term safety data.
Dabigatran “has already been proven to be a safe and efficacious anticoagulant treatment for stroke prevention in patients with atrial fibrillation,” said Professor Frans Van de Werf (University Hospitals Leuven, Belgium). “However, the presence of a mechanical heart valve is a distinct clinical situation requiring different dosing. The aim of the RE-ALIGN study is to identify dosing regimens… that are expected to be safe and effective for the prevention of thromboembolic complications in patients with mechanical heart valves”.
1. Van de Werf F, Brueckmann M, et al. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN). Am Heart J 2012; http://dx.doi.org/10.1016/j.ahj.2012.03.011
Published on: July 24, 2012
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