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

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ClinicalTrials.gov Identifier: NCT01158703
Recruitment Status : Terminated (poor recruitment and reduction in CT surgery support)
First Posted : July 8, 2010
Results First Posted : May 19, 2015
Last Update Posted : May 19, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ahmad Slim, Brooke Army Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Coronary Graft Patency
Interventions Drug: clopidogrel
Drug: sugar pill
Drug: Aspirin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description

aspirin and clopidogrel

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

aspirin and placebo

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

Period Title: Overall Study
Started 12 8
Completed 12 8
Not Completed 0 0
Arm/Group Title Clopidogrel Sugar Pill Total
Hide Arm/Group Description

aspirin and clopidogrel

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

aspirin and placebo

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

Total of all reporting groups
Overall Number of Baseline Participants 12 8 20
Hide Baseline Analysis Population Description
Two active treatment groups
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 8 participants 20 participants
67.4  (9.7) 64.8  (10.2) 66.4  (9.9)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 8 participants 20 participants
Female
1
   8.3%
1
  12.5%
2
  10.0%
Male
11
  91.7%
7
  87.5%
18
  90.0%
[1]
Measure Description: Gender distribution among groups
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 8 participants 20 participants
12 8 20
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 12 participants 8 participants 20 participants
117.8  (10.7) 115.4  (12.34) 116.8  (11.6)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 12 participants 8 participants 20 participants
69.5  (9.1) 65.1  (7.3) 67.8  (8.5)
1.Primary Outcome
Title Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone
Hide Description Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description:

aspirin and clopidogrel

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

aspirin and placebo

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

Overall Number of Participants Analyzed 12 8
Overall Number of Units Analyzed
Type of Units Analyzed: Grafts
36 27
Measure Type: Number
Unit of Measure: occluded grafts
10 9
2.Secondary Outcome
Title Incidence of Bleeding Between the Two Treatment Arms
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description:

aspirin and clopidogrel

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

aspirin and placebo

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

Overall Number of Participants Analyzed 12 8
Measure Type: Number
Unit of Measure: BLEEDING EVENTS
0 0
3.Secondary Outcome
Title Number of Major Adverse Cardiovascular Events With Combination Therapy
Hide Description Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
above is the total number of all events reported
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description:

aspirin and clopidogrel

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

aspirin and placebo

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

Overall Number of Participants Analyzed 12 8
Overall Number of Units Analyzed
Type of Units Analyzed: All events
10 6
Measure Type: Number
Unit of Measure: MACE Events over 52Wks
10 6
4.Secondary Outcome
Title Number of Angina Events
Hide Description Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
above is the total number of participants
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description:

aspirin and clopidogrel

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

aspirin and placebo

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

Overall Number of Participants Analyzed 12 8
Measure Type: Number
Unit of Measure: Angina Events over 52Wks
7 5
5.Secondary Outcome
Title Number of Myocardial Infarction Events
Hide Description Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
above is the total number of participants
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description:

aspirin and clopidogrel

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

aspirin and placebo

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

Overall Number of Participants Analyzed 12 8
Measure Type: Number
Unit of Measure: MI Events over 52Wks
2 1
6.Secondary Outcome
Title Number of Thrombotic Events
Hide Description Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
above is the total number of participants
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description:

aspirin and clopidogrel

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

aspirin and placebo

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

Overall Number of Participants Analyzed 12 8
Measure Type: Number
Unit of Measure: thrombotic Events over 52Wks
1 0
Time Frame 52 weeks
Adverse Event Reporting Description 52 weeks events of bleeding ( TIMI Major and Minor)
 
Arm/Group Title Clopidogrel Sugar Pill
Hide Arm/Group Description

aspirin and clopidogrel

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

aspirin and placebo

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

All-Cause Mortality
Clopidogrel Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/12 (83.33%)      6/8 (75.00%)    
Cardiac disorders     
Number of Angina Events  1 [1]  7/12 (58.33%)  7 5/8 (62.50%)  5
Number of Myocardial Infarction Events  1 [2]  2/12 (16.67%)  2 1/8 (12.50%)  1
Vascular disorders     
Number of Thrombotic Events  1 [3]  1/12 (8.33%)  1 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, TIMI trials
[1]
Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone
[2]
Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone
[3]
Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clopidogrel Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
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.
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
Responsible Party: Ahmad Slim, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01158703     History of Changes
Other Study ID Numbers: C.2009.120
First Submitted: July 7, 2010
First Posted: July 8, 2010
Results First Submitted: February 23, 2015
Results First Posted: May 19, 2015
Last Update Posted: May 19, 2015