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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Collaborator: The TIMI Study Group
• Treatments: Edoxaban; Warfarin

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