Date: 2016-11-11
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Boehringer Ingelheim (Germany)
Product: dabigatran etexilate
Action
mechanism: thrombin inhibitor. Dabigatran is a non-vitamin K antagonist oral anticoagulant with an approved reversal agent, idarucizumab. The compound is a direct thrombin inhibitor.
Disease: non-valvular atrial fibrillation
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: RE-DUAL PCI™ evaluates dual therapy with dabigatran etexilate vs. triple therapy with warfarin in atrial fibrillation patients undergoing percutaneous coronary intervention with stenting. The study has randomised 2,727 adult patients undergoing PCI with stenting (elective or due to an acute coronary syndrome) at 550 sites in over 40 countries worldwide. The main objective of the study is to compare a dual antithrombotic therapy regimen of either 150mg or 110mg dabigatran etexilate twice daily plus clopidogrel or ticagrelor versus a triple antithrombotic therapy combination of warfarin plus clopidogrel or ticagrelor plus aspirin <= 100mg once daily. The primary safety endpoint of the 30 month study is the time to first major bleeding event, as defined by the International Society on Thrombosis and Haemostasis (ISTH), or clinically relevant non-major bleeding event. The secondary outcome measures include composite efficacy endpoints of time to death or first thrombotic event (all death, myocardial infarction, stroke or systemic embolism) and unplanned revascularisation.
Latest
news: * On November 11, 2016, Boehringer Ingelheim announced that patient enrolment into the international Phase IIIb RE-DUAL PCI™ study is complete. The study evaluates the safety and efficacy of dabigatran etexilate (marketed as Pradaxa®) in atrial fibrillation (AF) patients undergoing a percutaneous coronary intervention (PCI) with stent placement. The results of the study are expected during the second half of 2017. * On August 19, 2014, Boehringer Ingelheim announces that the first patients have been enrolled in the company’s new international phase III study, RE-DUAL PCI™.1 The study will evaluate the efficacy and safety of the oral anticoagulant dabigatran etexilate in patients with an irregular heartbeat called non-valvular atrial fibrillation (AF), 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. 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.2 The study will enroll 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.
