ENVISAGE TAVI-AF

Edoxaban vs. Standard of Care and their effects on clinical inpatients having undergone transcatheter aortic valve implantation - in atrial fibrillation

20/07/2017 to 31/12/2022

Study design: This is a multinational, multicenter, prospective,randomized, open-label study with blinded evaluation of endpoints (PROBE) parallel group study comparing Edoxaban with VKA in subjects with AF having undergone TAVI. Critical events will be adjudicated by an independent Clinical Event Committee (CEC). An independent Data and Safety Monitoring Board (DSMB) is responsible for monitoring safety during the study.
Indication Under Investigation: Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)
Co-Primary objectives: To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke,
systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).
Secondary objectives: To compare Edoxaban with VKA with regard to defined efficacy and safety endpoints.