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RE-DUAL PCI trial will assess Pradaxa in patients with nonvalvular AF after PCI
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Boehringer Ingelheim announced the start of patient enrollment for the international, phase 3 RE-DUAL PCI trial, which will assess the use of oral anticoagulant dabigatran etexilate in patients with nonvalvular atrial fibrillation after PCI.
The trial will compare the safety and efficacy of dual antithrombotic therapy with dabigatran (Pradaxa, Boehringer Ingelheim) plus clopidogrel or ticagrelor (Brilinta, AstraZeneca) vs. the currently recommended standard triple antithrombotic therapy regimen with warfarin and clopidogrel or ticagrelor plus acetylsalicylic acid. Dabigatran will be assessed at doses of 110 mg or 150 mg twice daily, according to a press release.
Christopher P. Cannon
RE-DUAL PCI will include a total of 8,500 patients enrolled at 700 sites in 50 countries. Study completion is anticipated in 2017, according to the release. The trial is part of the RE-VOLUTION clinical trial program, which comprises 15 trials and more than 60,000 patients worldwide.
“Currently there are limited data about appropriate anticoagulation treatment in patients with AF undergoing PCI,” lead investigator Christopher P. Cannon, MD, executive director of cardiometabolic trials at Harvard Clinical Research Institute, stated in the release. “We expect this study to provide data that can help us better understand how to prevent stroke and stent thrombosis, while at the same time minimizing bleeding risk in this especially vulnerable patient population.”