Trial Details

Acronym: Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation

Purpose: Evaluated apixaban versus warfarin in patients with atrial fibrillation or flutter

Format: randomized, double-blind

Treatment Group 1: apixaban (at a dose of 5 mg twice daily)

Treatment Group 2: warfarin

Number of Patients: 18,201

Inclusion Criteria:

  • Atrial fibrillation
  • At least one of the following:
    • Least 75 years of age
    • Previous stroke
    • Transient ischemic attack or systemic embolism
    • Symptomatic heart failure within the previous 3 months
    • Left ventricular ejection fraction of no more than 40%
    • Diabetes mellitus
    • Hypertension requiring pharmacologic treatment

Exclusion Criteria:

  • AF due to a reversible cause
  • Moderate or severe mitral stenosis
  • Conditions other than AF that required anticoagulation
  • Stroke within the previous 7 days
  • A need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel
  • Severe renal insufficiency

Primary Endpoint: ischemic or hemorrhagic stroke or systemic embolism

Secondary Endpoints:

Follow-up: mean 2 years


The ARISTOTLE trial found that apixaban had lower rates of stroke, systemic embolism, major bleeding and reduced mortality compared to warfarin.

Original Publication:

Granger CB et al. N Engl J Med. 2011;doi: 10.1056/NEJMoa1107039.