A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00852397
First received: February 26, 2009
Last updated: August 27, 2013
Last verified: August 2013
Results First Received: June 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Apixaban
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Apixaban 2.5 mg BID Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
Apixaban 5.0 mg BID Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.

Participant Flow:   Overall Study
    Placebo     Apixaban 2.5 mg BID     Apixaban 5.0 mg BID  
STARTED     52     49     50  
Treated Participants     51     49     49  
COMPLETED     41     41     36  
NOT COMPLETED     11     8     14  
Adverse Event                 4                 6                 4  
Death                 0                 0                 1  
Withdrawal by Subject                 4                 1                 2  
Study terminated by sponsor                 2                 1                 6  
Difficulty in study site visit                 1                 0                 0  
Protocol Violation                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo

Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.

Number of participants in baseline characteristics means randomized participants.

Apixaban 2.5 mg BID

2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.

Number of participants in baseline characteristics means randomized participants.

Apixaban 5.0 mg BID

Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.

Number of participants in baseline characteristics means randomized participants.

Total Total of all reporting groups

Baseline Measures
    Placebo     Apixaban 2.5 mg BID     Apixaban 5.0 mg BID     Total  
Number of Participants  
[units: participants]
  52     49     50     151  
Age  
[units: years]
Mean ± Standard Deviation
  63.9  ± 10.1     66.0  ± 9.0     64.0  ± 9.2     64.6  ± 9.5  
Gender  
[units: participants]
       
Female     10     6     4     20  
Male     42     43     46     131  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.   [ Time Frame: Week 0 to Week 24 ]

2.  Secondary:   Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.   [ Time Frame: Week 0 to Week 24 ]

3.  Secondary:   Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.   [ Time Frame: Week 0 to Week 24 ]

4.  Secondary:   Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.   [ Time Frame: Week 0 to Week 24 ]

5.  Secondary:   Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.   [ Time Frame: For 30 days after Week 24 or the discontinuation of study drug ]

6.  Secondary:   Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.   [ Time Frame: From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]) ]

7.  Other Pre-specified:   Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.   [ Time Frame: Week 0 to Week 24 ]

8.  Other Pre-specified:   Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.   [ Time Frame: Week 0 to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00852397     History of Changes
Other Study ID Numbers: B0661004
Study First Received: February 26, 2009
Results First Received: June 4, 2013
Last Updated: August 27, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency