Status:
COMPLETED
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
The TIMI Study Group
Conditions:
Stroke
Atrial Fibrillation
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief 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 embo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
21105 Patients enrolled
Trial Details
Trial ID
NCT00781391
Start Date
November 1 2008
End Date
May 1 2013
Last Update
March 5 2019
Active Locations (1009)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States