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

Official Title: “A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF”

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.

Intervention(s) in this Clinical Trial

• Drug: Apixaban
  • Apixaban 5 mg tablet BID for 12 weeks
• Drug: Apixaban
  • Apixaban 2.5 mg tablet BID for 12 weeks
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Apixaban 5mg BID
• Experimental: Apixaban 2.5mg BID
• Active Comparator: Warfarin

Primary Measures

• Incidence of adjudicated major or clinically relevant non-major bleeding during the treatment period
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Incidence of adjudicated myocardial infarction or all-cause death during the treatment period
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Incidence of major bleeding during the treatment period
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Other safety outcome measures will also be assessed, including serious and non-serious AEs and changes in standard clinical laboratory test results
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Incidence of adjudicated stroke or systemic embolism during the treatment period
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Incidence of adjudicated stroke, systemic embolism or all-cause death during the treatment period
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Incidence of total bleeding (major bleeding, clinically relevant non-major bleeding, and minor bleeding) during the treatment period
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00787150

Study ID Number: B0661003

ClinicalTrials.gov Identifier: NCT00787150

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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