Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation "EngageAFTIMI48"


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

- 21 years of age or older; male or female.
- Able to provide written informed consent.
- History of documented AF within the prior 12 months
- A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria

- Transient atrial fibrillation secondary to other reversible disorders
- Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
- Subjects with any contraindication for anticoagulant agents;
- Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
- Females of childbearing potential including the following:
- Females with a history of tubal-ligation
- Females less than 2 years post-menopausal