August 2, 2015
The first U.S. patients have been enrolled in the RE-DUAL PCI and RE-CIRCUIT trials of the safety and efficacy of dabigatran in patients with nonvalvular atrial fibrillation, according to a press release from Boehringer Ingelheim.
The event-driven, open-label RE-DUAL PCI trial will include approximately 8,520 patients with nonvalvular AF who have undergone PCI with stent placement. Patients will receive dabigatran (Pradaxa) 110 mg or 150 mg twice daily, in addition to antiplatelet therapy with clopidogrel or ticagrelor (Brilinta, AstraZeneca), or standard triple therapy with warfarin and two antiplatelet therapies. The primary efficacy endpoint is time to death, MI, stroke or systemic embolism and the primary safety endpoint is time to first major bleeding event. The endpoints will be assessed at several time points for up to 30 months after randomization. The trial will be conducted at 401 international centers. Results are anticipated in 2017, according to the release.