Aspirin and Plavix Following Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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The design of the study will be randomized, double blind trial, which will examine the effects of addition of clopidogrel to current guideline recommended background therapy on lowering the incidence of graft stenosis after coronary artery bypass grafting compared to placebo.

Detailed Description
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The purpose of this study is to evaluate how well the combination of clopidogrel and aspirin lower the risk of clot forming in the bypass graft after open heart surgery. This combination has not yet been approved by the Food & Drug Administration (FDA) for treating clots in the bypass graft. However, the FDA has not objected to its use to study its safety and effectiveness. This study will enroll approximately 150 total subjects all of which will be at Brooke Army Medical Center/Wilford Hall Medical Center. The study will be for 52 weeks from the day of surgery. After bypass surgery and inclusion criteria is met, subjects will be placed on aspirin 81 mg once daily and placebo once daily or aspirin 81 mg once daily and clopidogrel 75mg once daily to keep the bypass grafts open after surgery. There are no studies to date comparing the two study groups A CT scan of the heart will be done 2 weeks after surgery to see if the grafts are still open. At the end of the study, at 52-weeks mark, the subjects will undergo another heart scan to evaluate the bypass grafts and see if they are still open. Subjects will be seen on a 3 months basis until the end of the study, unless deemed necessary to return earlier for follow up. Subjects will undergo blood draw for complete blood count as part of the follow up visits to assess for safety while on the current study drug.

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

Conditions
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Coronary Graft Patency

Intervention / Treatment
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* Drug: clopidogrel
* Drug: sugar pill
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary bypass Age ≥ 18 Exclusion Criteria: Left ventricle ejection fraction <30% Emergency surgery Valve surgery Redo CABG Postoperative cardiogenic shock for more than 48 hours Postoperative bleeding or cardiac tamponade More than 24 hours postoperative intubation course Requirement of postoperative anticoagulation Serum creatinine >1.4 Contraindication to use of postoperative coronary CT scan Allergy or contraindication to aspirin or clopidogrel Inability to provide informed consent Pregnant or breast feeding females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clopidogrel<br>aspirin and clopidogrel | Drug: clopidogrel<br>* clopidogrel 75mg daily by mouth daily for 12 months<br>* Other names: Plavix;Drug: Aspirin<br>* aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)<br>* Other names: ASA, acetylsalicylic acid, Ecotrin, Fasprin;|
| Placebo Comparator: sugar pill<br>aspirin and placebo | Drug: sugar pill<br>* sugar pill by mouth daily for 12 months<br>* Other names: placebo;Drug: Aspirin<br>* aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)<br>* Other names: ASA, acetylsalicylic acid, Ecotrin, Fasprin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone | Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Bleeding Between the Two Treatment Arms |  | 52 weeks | 
| Number of Major Adverse Cardiovascular Events With Combination Therapy | Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks | 
| Number of Angina Events | Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks | 
| Number of Myocardial Infarction Events | Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks | 
| Number of Thrombotic Events | Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, clopidogrel, coronary artery bypass graft, Plavix