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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apixaban 5mg BID

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Apixaban 5 mg tablet BID for 12 weeks

Apixaban 2.5mg BID

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Apixaban 2.5 mg tablet BID for 12 weeks

Warfarin

Group Type ACTIVE_COMPARATOR

Warfarin sodium

Intervention Type DRUG

At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Interventions

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Apixaban

Apixaban 5 mg tablet BID for 12 weeks

Intervention Type DRUG

Apixaban

Apixaban 2.5 mg tablet BID for 12 weeks

Intervention Type DRUG

Warfarin sodium

At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No