ProjektENVISAGE TAVI-AF – Edoxaban vs. Standard of Care and their effects on clinical inpatients having undergone…
Grunddaten
Akronym:
ENVISAGE TAVI-AF
Titel:
Edoxaban vs. Standard of Care and their effects on clinical inpatients having undergone transcatheter aortic valve implantation - in atrial fibrillation
Laufzeit:
20.07.2017 bis 31.12.2022
Abstract / Kurz- beschreibung:
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.
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.
Schlüsselwörter:
Neue orale Antikoagulantien
TAVI
Vorhofflimmern
atrial fibrillation
Edoxaban
Herzklappenersatz
Beteiligte Mitarbeiter/innen
Leiter/innen
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Ansprechpartner/innen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Lokale Einrichtungen
Abteilung Innere Medizin III
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Geldgeber
Parsippany, New Jersey, Vereinigte Staaten