Global Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (Engage-AF TIMI-48)
- Registration Number
- CTRI/2009/091/000165
- Lead Sponsor
- Daiichi Sankyo Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
-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:
oFemales with a history of tubal-ligation
oFemales less than 2 years post-menopausal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method