ENTRUST-AF-PCI

Evaluation of the safety and efficacy of an edoxaban-basedcompared to a vitamin K antagonist-based antithrombotic regimenfollowing successful percutaneous coronary intervention (PCI)with stent placement. (EdoxabaN Treatment versus VKA inpatients with AF undergoing PCI)

25/09/2017 to 31/12/2019

The primary objective: is to compare a 12-month antithromboticregimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12 antagonist and 1-12 months ASA in subjects with AF following successful PCI with stent placement in terms of the incidence of
major or clinically relevant non-major ISTH-defined bleeding (MCRB).
Secondary exploratory objectives of the study: are to compare the edoxaban-based antithrombotic regimen to the VKA-based antithrombotic regimen with regard to: Main efficacy endpoint (MEE), defined as the composite of cardiovascular (CV) death, stroke, systemic embolic events (SEE), spontaneous myocardial infarction (MI) and definite stent thrombosis; and more such as: bleeding, stroke, all-cause-death...