Boehringer Ingelheim has announced that the first US patients have been enrolled in its international clinical trial—RE-DUAL PCI, which is evaluating the efficacy and safety of dabigatran in patients with non-valvular atrial fibrillation who have undergone percutaneous coronary intervention (PCI). Patients have also been enrolled in RE-CIRCUIT, which is looking at the safety of using the drug in patients who are undergoing a first ablation procedure.
RE-DUAL PCI (Randomized evaluation of dual therapy with dabigatran vs. triple therapy with warfarin in patients with non-valvular atrial fibrillation patients that have undergone PCI with stenting) is an event-driven, open-label trial that will evaluate dual therapy of dabigatran (Pradaxa; 150 mg or 110 mg twice daily) plus single antiplatelet therapy (clopidogrel or ticagrelor) compared with the current standard of care of triple therapy—warfarin plus two antiplatelet agents (clopidogrel or ticagrelor, and aspirin in the trial). The aim of the study is to enrol more than 8,520 patients at 401 study locations around the globe.
Lead investigator Christopher Cannon (cardiologist, Brigham and Women’s Hospital; professor of Medicine, Harvard Medical School, Boston, USA), says: “Currently there are limited data about appropriate anticoagulation treatment for patients with non-valvular atrial fibrillation undergoing PCI, but with the plan to enrol more than 8,500 patients, we expect RE-DUAL PCI to provide robust data to help us better understand and care for this patient population.”
The study’s primary efficacy endpoint is the time to death or first thrombotic event (all death, myocardial infarction, stroke or systemic embolism), and the primary safety endpoint is the time to first major bleeding event, as defined by the International Society of Haematology (ISTH). Secondary endpoints include time to the individual events included in the primary efficacy endpoint. All endpoints will be assessed at time points up to 30 months following randomisation to the three treatment groups. Results of the study are expected in 2017.
The open label RE-CIRCUIT (Randomised evaluation of dabigatran etexilate compared to warfarin in pulmonary vein ablation: assessment of different peri-procedural anticoagulation strategy) study will evaluate the safety of uninterrupted treatment with dabigatran 150mg twice daily compared with uninterrupted warfarin (International Normalized Ratio [INR] of 2.0 to 3.0) in non-valvular atrial fibrillation patients undergoing a first ablation procedure. The trial will enrol an estimated 724 patients at 85 international study locations.
Hugh Calkins, chairman of the RE-CIRCUIT Study Steering Committee and professor of Cardiology and director of the Electrophysiology Laboratory and Arrhythmia Service, Johns Hopkins Hospital, Baltimore, USA, states: “The RE-CIRCUIT trial provides an important opportunity to expand knowledge and the potential to help inform guidelines for appropriate use of novel oral anticoagulants in non-valvular atrial fibrillation patients undergoing ablation procedures.”