Advertisement Boehringer enrols first patient in Re-Circuit trial of dabigatran etexilate to treat AF - Pharmaceutical Business review
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Boehringer enrols first patient in Re-Circuit trial of dabigatran etexilate to treat AF

Boehringer Ingelheim has enrolled first patient in the global Re-Circuit trial, which is designed to evaluate the safety and efficacy of uninterrupted anticoagulation with dabigatran etexilate (Pradaxa) during ablation procedures compared to warfarin for the treatment of atrial fibrillation (AF).

The Re-Circuit trial will compare the use of uninterrupted dabigatran 150mg twice daily to uninterrupted warfarin in AF patients undergoing an ablation procedure.

Around 700 patients with either intermittent or permanent AF will be enrolled in the trial with treatment equally and randomly split between dabigatran 150mg twice daily or warfarin.

The company said that the overarching Re-Volution clinical trial program for dabigatran includes 14 international phase III trials involving more than 55,000 patients in over 44 countries across the world.

Johns Hopkins Hospital professor of Cardiology and director of the Electrophysiology Laboratory and Arrhythmia Service and chairman of the Re-Circuit Study Steering Committee professor Hugh Calkins said: "Re-Circuit will offer the first comprehensive understanding on the performance of uninterrupted dabigatran during AF ablation.

"We already know that dabigatran effectively prevents stroke and systemic embolism in patients with AF.

"We believe that dabigatran can simplify ablation management for physicians and provide a beneficial alternative to standard anticoagulation with warfarin."

The safety and efficacy of the therapies will be evaluated during the three-four month treatment period and follow-up visit one week after treatment end.

In the Re-Circuit trial, patients will be screened with a transoesophageal echocardiogram before their ablation procedure to determine whether there is a thrombus present in the upper left heart chamber (left atrium).

Results from the Re-Circuit study are expected to be reported during 2016.