Project AUGUSTUS – An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety ofApixaban…

Basic data

Acronym:
AUGUSTUS
Title:
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
Duration:
06/04/2017 to 31/12/2019
Abstract / short description:
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.
Keywords:
cardiovascular disease
Herzkreislauferkrankungen
Apixaban
atrial fibrillation
Vorhofflimmern
PTCA
Vitamin K Antagonisten

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

Nürnberg, Bayern, Germany
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