ProjektAUGUSTUS – An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety ofApixaban…
Grunddaten
Akronym:
AUGUSTUS
Titel:
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety ofApixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and AcuteCoronary Syndrome or Percutaneous Coronary Intervention
Laufzeit:
06.04.2017 bis 31.12.2019
Abstract / Kurz- beschreibung:
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety ofApixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and AcuteCoronary Syndrome or Percutaneous Coronary Intervention. Objectives:
- To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTH major or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI with planned concomitant P2Y12 inhibitor therapy.
-To determine if anticoagulant plus single antiplatelet therapy with a P2Y12 inhibitor is superior to anticoagulant plus dual antiplatelet therapy with a P2Y12 inhibitor and aspirin on the combined outcome of ISTH major or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI with planned concomitant P2Y12 inhibitor therapy.
- To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTH major or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI with planned concomitant P2Y12 inhibitor therapy.
-To determine if anticoagulant plus single antiplatelet therapy with a P2Y12 inhibitor is superior to anticoagulant plus dual antiplatelet therapy with a P2Y12 inhibitor and aspirin on the combined outcome of ISTH major or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI with planned concomitant P2Y12 inhibitor therapy.
Schlüsselwörter:
Herzkreislauferkrankungen
cardiovascular disease
Apixaban
Vorhofflimmern
atrial fibrillation
PTCA
Vitamin K Antagonisten
Beteiligte Mitarbeiter/innen
Leiter/innen
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
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
Nürnberg, Bayern, Deutschland