At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation
In Brief
A Phase 3 clinical trial evaluating Edoxaban, Warfarin, and 1 other intervention for Atrial Fibrillation. Completed, enrolled 2,199 participants across 228 sites in 19 countries.
Detailed Summary
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.
Study Details
Timeline
Interventions
Edoxaban 30 mg tablets for oral administration
Warfarin tablet, 1.0 or 2.5 mg, for oral administration
Enoxaparin per label, at prescribed dose until PT INR at least 2.0