What is the optimal antithrombotic strategy for patients with both atrial fibrillation and acute coronary syndrome??
AUGUSTUS
An Open-Label, 2 x 2 Factorial, Randomized Controlled Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention
Testing 123
Study Focus:
AUGUSTUS is a three-year, two-by-two factorial, randomized controlled trial that is evaluating the safety of apixaban, with and without aspirin use, versus other vitamin K antagonists in patients with nonvalvular atrial fibrillation (NVAF) and coronary artery disease (CAD) where the use of a P2Y12 inhibitor is indicated for at least 6 months.
Study Population:
4,600 men and women, from 30 countries, age 18 and older with NVAF with the planned or existing use of an oral anticoagulant for reducing the risk of thromboembolism. Duke Clinical Research Institute is the global leader for the AUGUSTUS study.
Clinical Events Classification Insight:
Duke Clinical Research Institute performed adjudication and confirmatory analysis on over 2,200 triggered events including bleeding, myocardial infarction, stroke, death, and stent thrombosis. Bristol-Myers Squibb provided statistical support, while the Pharmaceutical Product Development, LLC (PPD) oversaw site, safety, and data management.
