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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.
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.
The current approval of Pradaxa does not cover the use in patients with mechanical heart valves.
Every year, approximately 300,000 patients undergo heart valve surgery worldwide, with numbers expected to rise in the future.
Mechanical valves are associated with a superior durability but also with a much higher and persistent risk of thromboembolism, requiring lifelong anticoagulation therapy.
Vitamin K antagonists, such as warfarin, are the current long-term standard for anticoagulation of patients with a cardiac valve replacement.
However, there is only limited information available on the long-term risk of thrombotic and haemorrhagic complications associated with this therapy in patients with modern mechanical bileaflet valves.
Additionally, in spite of frequent INR monitoring, patients treated with warfarin spend less than 65% of the time within the targeted therapeutic range (TTR), with TTR in the first three months following valve replacement surgery reported to be as low as 48.5%.
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, commented: “It is vital that patients with mechanical heart valves are provided with anticoagulant therapies that are safe and effective over the long term.
“The current treatment with vitamin K antagonists is associated with significant limitations, creating a need for novel options which have fewer interactions and do not require regular monitoring.
“We are proud to be the first company looking for an alternative option for these patients by investigating Pradaxa in the RE-ALIGN trial.”