A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Bristol-Myers Squibb
• Treatments: Apixaban; Warfarin

Criteria

Inclusion Criteria:

• Age ≥ 20 years outpatient (regardless of sex)

• Patients diagnosed as non-valvular atrial fibrillation (NVAF)

• One or more following risks of stroke.

Exclusion Criteria:

• Recent cerebral infarction (includes TIA) within 4 weeks of week 0.

• Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).

• Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.