An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

- Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
- History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus

Exclusion Criteria

- Significant mitral stenosis
- Transient atrial fibrillation caused by a reversible disorder
- Active internal bleeding
- Severe disabling stroke
- History of intracranial bleeding
- Hemorrhagic disorders