Conditions: Atrial Fibrillation Stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief summary:
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

Detailed description:

Arms:
arm 1: DU-176b tablets: high-dose arm 2: Warfarin tablets arm 3: DU-176b tablets: low-dose

Interventions: intervention 1: DU-176b tablets intervention 2: DU-176b tablets intervention 3: Warfarin tablets
Intervention descriptions: intervention 1: DU-176b tablets taken once daily for up to 3 months intervention 2: DU-176b tablets taken once daily for up to 3 months intervention 3: Warfarin tablets taken once daily for up to 3 months

Protocol document: