A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Edoxaban; Warfarin

Criteria

Inclusion Criteria:

1. Male or female, 18 to 80 years old.

2. Able to provide written informed consent.

3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)

4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

Exclusion Criteria:

1. Subjects with mitral valve disease or previous valvular heart surgery

2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin

3. Known or suspected hereditary or acquired bleeding or coagulation disorder