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

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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.


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
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