Enrollment begins for two trials of dabigatran

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.

The open-label RE-CIRCUIT trial will include approximately 724 patients with nonvalvular AF who are undergoing a first ablation procedure. The patients will be assigned to 150 mg dabigatran twice daily or uninterrupted warfarin. The primary endpoint is major bleeding and secondary endpoints include minor bleeding, stroke, systemic embolism and transient ischemic attack. Researchers will evaluate the endpoints during ablation and for up to 2 months following the procedure, according to the release.

The international RE-DUAL PCI and RE-CIRCUIT trials are part of the company’s RE-VOLUTION clinical trial program. 

Source: www.healio.com