Conditions: Stroke Atrial Fibrillation Embolism
Keywords: Systemic embolic events
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21105
Healthy volunteers: no

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 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.

Detailed description:

Arms:
arm 1: Warfarin tablets plus placebo Edoxaban tablets arm 2: Edoxaban tablets (60mg) plus warfarin placebo tablets arm 3: Edoxaban tablets (30mg) plus warfarin placebo tablets

Interventions: intervention 1: warfarin tablets intervention 2: Edoxaban tablets (high dose regimen-60mg) intervention 3: Edoxaban tablets (low dose regimen-30mg) intervention 4: placebo warfarin intervention 5: placebo edoxaban
Intervention descriptions: intervention 1: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months intervention 2: Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months intervention 3: Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months intervention 4: placebo warfarin intervention 5: placebo edoxaban

Protocol document: