Boehringer Ingelheim has announced that the first patients have been enrolled in the company’s new international phase III study, RE-DUAL PCI. The study will evaluate the efficacy and safety of the oral anticoagulant dabigatran etexilate in patients with non-valvular atrial fibrillation, who have undergone a percutaneous coronary intervention (PCI) with stent placement to widen their blocked coronary arteries.
RE-DUAL PCI aims to advance medical knowledge and guide future antithrombotic treatment choice for greatest patient benefit. It addresses the need for innovative new treatment regimens to improve patient prognosis.
“Currently there are limited data about appropriate anticoagulation treatment in patients with atrial fibrillation undergoing PCI,” says Christopher Cannon, RE-DUAL PCI lead investigator and executive director, Cardiometabolic Trials, Harvard Clinical Research Institute. “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 minimising bleeding risk in this especially vulnerable patient population,” says Cannon, who also is a cardiologist at Brigham and Women’s Hospital in Boston and a professor of Medicine, Harvard Medical School.
The RE-DUAL PCI study will compare the efficacy and safety of dual antithrombotic therapy with dabigatran etexilate (110mg or 150mg twice daily) plus clopidogrel or ticagrelor versus the currently recommended standard triple antithrombotic therapy regimen with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor plus acetylsalicylic acid. The study will enrol approximately 8,500 patients at 700 sites in over 40 countries around the globe. Boehringer Ingelheim is conducting the study cooperatively with the Harvard Clinical Research Institute.
“Boehringer Ingelheim is confident in the ability of dabigatran etexilate to safely reduce the risk of thromboembolic events when used as directed and is committed to expanding the scientific knowledge of dabigatran use in atrial fibrillation patients who undergo significant procedures for their cardiac conditions,” says Klaus Dugi, chief medical officer, Boehringer Ingelheim. “We look forward to the continuing enrolment of patients in RE-DUAL PCI and expect to have full results in 2017.”
RE-DUAL PCI is part of Boehringer Ingelheim’s extensive clinical trial programme, RE-VOLUTION. With the recently announced RE-CIRCUIT and RE-SPECT ESUS studies, the entire programme will include 15 clinical trials involving over 60,000 patients in more than 100 countries globally.