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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Apixaban; Drug: Warfarin sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00787150

B0661003

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 3 patient groups

Apixaban 5mg BID

Experimental group

Treatment:

Drug: Apixaban

Drug: Apixaban

Apixaban 2.5mg BID

Experimental group

Treatment:

Drug: Apixaban

Drug: Apixaban

Warfarin

Active Comparator group

Treatment:

Drug: Warfarin sodium