Germany-based Boehringer Ingelheim has enrolled the first patients in its new RE-DUAL PCI international phase III study to evaluate dabigatran etexilate in atrial fibrillation (AF) patients after percutaneous coronary intervention (PCI) with stenting.
The RE-DUAL PCI study will assess the efficacy and safety of the oral anticoagulant dabigatran etexilate in patients with an irregular heartbeat, known as non-valvular AF, and who have undergone a percutaneous coronary intervention (PCI) with stent placement to widen their blocked coronary arteries.
Harvard Clinical Research Institute Cardiometabolic Trials executive director and RE-DUAL PCI lead investigator professor Christopher Cannon said: "Currently, there are limited data about appropriate anticoagulation treatment in patients with AF undergoing PCI.
"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."
Around 8,500 patients will be enrolled at 700 sites in more than 40 countries, for the study that will be carried out by Boehringer in close cooperation with Harvard Clinical Research Institute.
The study will involve the comparison of the efficacy and safety of dual antithrombotic therapy with dabigatran etexilate (110mg or 150mg twice daily) plus clopidogrel or ticagrelor against the currently recommended standard triple antithrombotic therapy regimen with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor plus acetylsalicylic acid.
Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "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 RE-VOLUTION, the company’s extensive clinical trials programme involving 15 clinical trials and more than 60,000 patients in over 100 countries across the world.
Image: Coronary angiography and angioplasty in acute myocardial infarction (left: RCA closed, right: RCA successfully dilated). Photo: courtesy of JHeuser.