None listed
Conditions
Interventions
Intervention1: DU-176b: Drug: DU-176b tablets (high dose regimen) DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months
Intervention2: DU-176b: Drug: DU-176b tablets (low d
Sponsors
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Eligibility
Inclusion criteria
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
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: o Females with a history of tubal-ligation o Females less than 2 years post-menopausal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare DU-176b to warfarin with regard to the composite primary endpoint of stroke and systemic embolic events. Safety Issue: No Timepoint: Time Frame: 24 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare DU-176b to warfarin with regard to the composite clinical outcome of stroke, SEE, and all-cause mortality Safety Issue: No To compare DU-176b to warfarin with regard to major bleeding events Safety Issue: Yes Timepoint: Time Frame: 24 Months | — |
Countries
India
Contacts
Public ContactMs. Suneela Thatte
Outcome results
None listed