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Boehringer Ingelheim initiates study of Pradaxa in patients undergoing AF ablation
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Boehringer Ingelheim announced the initiation of the RE-CIRCUIT trial, which will assess the use of uninterrupted treatment with Pradaxa compared with warfarin in patients with paroxysmal or persistent nonvalvular atrial fibrillation who are scheduled to undergo a first ablation procedure, according to a press release.
RE-CIRCUIT is one of several trials within the RE-VOLUTION clinical trial program for dabigatran (Pradaxa). The program is evaluating the use of the drug for different indications and populations across a total of 15 studies in more than 55,000 patients worldwide.
The RE-CIRCUIT study will include 610 patients assigned twice-daily dabigatran 150 mg or warfarin at an international normalized ratio (INR) of 2 to 3. Patients will be followed for 90 days following ablation, according to the release.
The primary endpoint is frequency of major bleeding within 90 days of the procedure, as defined by the International Society of Hematology. Other evaluated endpoints include stroke or systemic embolism within 30 and 90 days of the procedure, major bleeding within 30 days, net clinical benefit at 30 and 90 days, incidence of complications related to vascular access, hemorrhagic pericardial effusion, pericardial tamponade and all-cause mortality, according to the release.
Hugh Calkins
“Currently there are no international guidelines regarding the specific use of novel oral anticoagulants during ablation procedures, despite their wide use in patients with AF,” Hugh Calkins, MD, FHRS, professor of cardiology at Johns Hopkins Hospital and chairman of the study steering committee, stated in the release. “We believe that dabigatran may provide a beneficial alternative to standard anticoagulation with warfarin during ablation procedures. The possibility to provide continuous anticoagulation with dabigatran during ablation would simplify management for physicians.”
The study results are expected in 2016, according to the release.