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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00787150
First received: November 5, 2008
Last updated: April 23, 2013
Last verified: April 2013
Results First Received: January 29, 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: Atrial Fibrillation
Interventions: Drug: Apixaban
Drug: Warfarin sodium

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Warfarin The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
Apixaban 2.5mg BID One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Apixaban 5.0 mg BID One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.

Participant Flow:   Overall Study
    Warfarin     Apixaban 2.5mg BID     Apixaban 5.0 mg BID  
STARTED     75 [1]   72 [1]   71 [1]
COMPLETED     66     65     66  
NOT COMPLETED     9     7     5  
Adverse Event                 4                 4                 4  
Physician Decision                 1                 2                 1  
Withdrawal by Subject                 2                 1                 0  
Dosing incorrect study durg                 2                 0                 0  
[1] Of 222 participants enrolled 4 discontinued before dosing, made a total of 218 participants started.



  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.
No text entered.

Reporting Groups
  Description
Warfarin The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
Apixaban 2.5mg BID One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Apixaban 5.0 mg BID One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Warfarin     Apixaban 2.5mg BID     Apixaban 5.0 mg BID     Total  
Number of Participants  
[units: participants]
  74     74     74     222  
Age  
[units: years]
Mean ± Standard Deviation
  71.7  ± 7.0     69.3  ± 8.4     70.0  ± 8.1     70.3  ± 7.9  
Gender  
[units: participants]
       
Female     14     11     13     38  
Male     60     63     61     184  



  Outcome Measures
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1.  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   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:   Number of Participants With Total Bleeding Events During the Treatment Period   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:   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 ]

4.  Secondary:   Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period   [ Time Frame: Baseline to Week 12 ]

5.  Secondary:   Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period   [ Time Frame: Baseline to Week 12 ]

6.  Secondary:   Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period   [ Time Frame: Baseline to Week 12 ]

7.  Secondary:   Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period   [ Time Frame: Baseline to Week 12 ]

8.  Other Pre-specified:   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 ]

9.  Other Pre-specified:   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 ]

10.  Other Pre-specified:   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 ]

11.  Other Pre-specified:   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 ]

12.  Other Pre-specified:   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 ]

13.  Other Pre-specified:   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 ]

14.  Other Pre-specified:   Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban   [ Time Frame: Week 0, Week 1, Week 8 ]


  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 by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787150     History of Changes
Other Study ID Numbers: B0661003
Study First Received: November 5, 2008
Results First Received: January 29, 2013
Last Updated: April 23, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency