Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Drug: warfarin; Drug: apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412984

CV185-030

Details and patient eligibility

About

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Enrollment: 20,976 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Males and females ≥ 18 yrs with atrial fibrillation (AF) and one or more of the following risk factors for stroke:
• Age ≥ 75, previous stroke
• transient ischemic attack (TIA) or Systemic Embolism (SE)
• Symptomatic congestive heart failure or left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40%
• Diabetes mellitus or hypertension requiring pharmacological treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20,976 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: warfarin

2

Experimental group

Treatment:

Drug: apixaban