Boehringer Ingelheim Corporation Release: First Study to Evaluate Alternative to Warfarin for Mechanical Heart Valve Patients Launched with Pradaxa® (dabigatran etexilate)

INGELHEIM, Germany--(BUSINESS WIRE)--The American Heart Journal has published 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.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 safe and effective dosing regimen of Pradaxa® for the prevention of valve thrombosis, stroke and systemic embolism in this patient population, prior to further investigation in a larger phase III study.1 The current approval of Pradaxa® does not cover the use in patients with mechanical heart valves.