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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787150
• Other study ID #: B0661003
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2008
• Last updated: April 23, 2013
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: April 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Apixaban 5 mg tablet BID for 12 weeks
• Apixaban
Apixaban 2.5 mg tablet BID for 12 weeks
• Warfarin sodium
At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Higashiibaraki-gunn Ibarakimachi	Ibaraki
Japan	Pfizer Investigational Site	Isezaki	Gunma
Japan	Pfizer Investigational Site	Iwakuni	Yamaguchi
Japan	Pfizer Investigational Site	Kawasaki	Kanagawa
Japan	Pfizer Investigational Site	Kitakyushu	Fukuoka
Japan	Pfizer Investigational Site	Kumamoto
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Ogaki	Gifu
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Seto	Aichi
Japan	Pfizer Investigational Site	Shibukawa	Gunma
Japan	Pfizer Investigational Site	Shinagawa-ku	Tokyo
Japan	Pfizer Investigational Site	Shinjuku-ku	Tokyo
Japan	Pfizer Investigational Site	Touon	Ehime
Japan	Pfizer Investigational Site	Tsu	Mie
Japan	Pfizer Investigational Site	Zentsuji	Kagawa

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban	Sample at 4 hours postdose was to be taken if possible.	0, 2, 4 hours postdose at Week 1 and Week 8	No
Other	Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban	Sample at 4 hours postdose was to be taken if possible.	Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8	No
Other	Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban	Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.	Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8	No
Other	Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban	Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.	Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8	No
Other	Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban	Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.	Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8	No
Other	Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban	Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.	Week 0, Week 1, Week 8	No
Other	Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban	Below the limit of quantification (BLQ) was assigned the value 0 for calculation.	Week 0, Week 1, Week 8	No
Primary	Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period	Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.	Baseline to Week 12	Yes
Secondary	Number of Participants With Total Bleeding Events During the Treatment Period	Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.	Baseline to Week 12	Yes
Secondary	Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period	Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.	Baseline to Week 12	Yes
Secondary	Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period	Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.	Baseline to Week 12	Yes
Secondary	Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period	The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.	Baseline to Week 12	No
Secondary	Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period	The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.	Baseline to Week 12	No
Secondary	Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period	The definition of the "Intended Treatment Period" was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.	Baseline to Week 12	No

External Links

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