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Trial record 1 of 1 for:    NCT00787150
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A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00787150
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : March 6, 2013
Last Update Posted : May 1, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 5, 2008
First Posted Date  ICMJE November 7, 2008
Results First Submitted Date  ICMJE January 29, 2013
Results First Posted Date  ICMJE March 6, 2013
Last Update Posted Date May 1, 2013
Study Start Date  ICMJE June 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
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 [ Time Frame: Baseline to Week 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
Incidence of adjudicated major or clinically relevant non-major bleeding during the treatment period [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT00787150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • Number of Participants With Total Bleeding Events During the Treatment Period [ Time Frame: Baseline to Week 12 ]
    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.
  • Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period [ Time Frame: Baseline to Week 12 ]
    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.
  • Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period [ Time Frame: Baseline to Week 12 ]
    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.
  • Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period [ Time Frame: Baseline to Week 12 ]
    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.
  • Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period [ Time Frame: Baseline to Week 12 ]
    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.
  • Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period [ Time Frame: Baseline to Week 12 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
  • Incidence of adjudicated myocardial infarction or all-cause death during the treatment period [ Time Frame: 12 weeks ]
  • Incidence of major bleeding during the treatment period [ Time Frame: 12 weeks ]
  • 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 ]
  • Incidence of adjudicated stroke or systemic embolism during the treatment period [ Time Frame: 12 weeks ]
  • Incidence of adjudicated stroke, systemic embolism or all-cause death during the treatment period [ Time Frame: 12 weeks ]
  • Incidence of total bleeding (major bleeding, clinically relevant non-major bleeding, and minor bleeding) during the treatment period [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2013)
  • Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban [ Time Frame: 0, 2, 4 hours postdose at Week 1 and Week 8 ]
    Sample at 4 hours postdose was to be taken if possible.
  • Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban [ Time Frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 ]
    Sample at 4 hours postdose was to be taken if possible.
  • Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban [ Time Frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 ]
    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.
  • Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban [ Time Frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 ]
    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.
  • Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban [ Time Frame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8 ]
    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.
  • Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban [ Time Frame: Week 0, Week 1, Week 8 ]
    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.
  • Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban [ Time Frame: Week 0, Week 1, Week 8 ]
    Below the limit of quantification (BLQ) was assigned the value 0 for calculation.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Apixaban 5mg BID
    Intervention: Drug: Apixaban
  • Experimental: Apixaban 2.5mg BID
    Intervention: Drug: Apixaban
  • Active Comparator: Warfarin
    Intervention: Drug: Warfarin sodium
Publications * Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. Epub 2011 Jun 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2009)
222
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2008)
250
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00787150
Other Study ID Numbers  ICMJE B0661003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP