Project ENTRUST-AF-PCI – Evaluation of the safety and efficacy of an edoxaban-basedcompared to a vitamin K…

Basic data

Acronym:
ENTRUST-AF-PCI
Title:
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)
Duration:
25/09/2017 to 31/12/2019
Abstract / short description:
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...

Involved staff

Managers

Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Faculty of Medicine
University of Tübingen

Local organizational units

Internal Medicine Department III
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine

Funders

Bad Homburg, Hessen, Germany
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