ARISTOTLE Trial

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

Summary:

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.