Aspirin and Plavix Following Coronary Artery Bypass Grafting (ASAP-CABG)

This study has been terminated.
(poor recruitment and reduction in CT surgery support)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ahmad Slim, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01158703
First received: July 7, 2010
Last updated: May 3, 2015
Last verified: May 2015
Results First Received: February 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Coronary Graft Patency
Interventions: Drug: clopidogrel
Drug: sugar pill
Drug: Aspirin

  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
Clopidogrel

aspirin and clopidogrel

clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months

Sugar Pill

aspirin and placebo

sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months


Participant Flow:   Overall Study
    Clopidogrel     Sugar Pill  
STARTED     12     8  
COMPLETED     12     8  
NOT COMPLETED     0     0  



  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.
Two active treatment groups

Reporting Groups
  Description
Clopidogrel

aspirin and clopidogrel

clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months

Sugar Pill

aspirin and placebo

sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months

Total Total of all reporting groups

Baseline Measures
    Clopidogrel     Sugar Pill     Total  
Number of Participants  
[units: participants]
  12     8     20  
Age  
[units: years]
Mean (Standard Deviation)
  67.4  (9.7)     64.8  (10.2)     66.4  (9.9)  
Gender [1]
[units: participants]
     
Female     1     1     2  
Male     11     7     18  
Region of Enrollment  
[units: participants]
     
United States     12     8     20  
Systolic Blood Pressure  
[units: mmHg]
Mean (Standard Deviation)
  117.8  (10.7)     115.4  (12.34)     116.8  (11.6)  
Diastolic Blood Pressure  
[units: mmHg]
Mean (Standard Deviation)
  69.5  (9.1)     65.1  (7.3)     67.8  (8.5)  
[1] Gender distribution among groups



  Outcome Measures
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1.  Primary:   Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone   [ Time Frame: 52 weeks ]

2.  Secondary:   Incidence of Bleeding Between the Two Treatment Arms   [ Time Frame: 52 weeks ]

3.  Secondary:   Number of Major Adverse Cardiovascular Events With Combination Therapy   [ Time Frame: 52 weeks ]

4.  Secondary:   Number of Angina Events   [ Time Frame: 52 weeks ]

5.  Secondary:   Number of Myocardial Infarction Events   [ Time Frame: 52 weeks ]

6.  Secondary:   Number of Thrombotic Events   [ Time Frame: 52 weeks ]


  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
The study did not recruit enough patients due to strict exclusion criteria and low volume of consenting patients resulting in a sample size that was insufficient for power analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: AHMAD M. SLIM, MD, LTC, MC
Organization: BROOKE ARMY MEDICAL CENTER
phone: 210-916-4717
e-mail: AHMAD.SLIM@US.ARMY.MIL


No publications provided


Responsible Party: Ahmad Slim, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01158703     History of Changes
Other Study ID Numbers: C.2009.120
Study First Received: July 7, 2010
Results First Received: February 23, 2015
Last Updated: May 3, 2015
Health Authority: United States: Federal Government