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 |
---|---|
Conditions: | Atrial Fibrillation, Cardiology, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 3/7/2019 |
Start Date: | November 2008 |
End Date: | May 2013 |
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
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.
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.
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
We found this trial at
312
sites
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