Aspirin and Plavix Following Coronary Artery Bypass Grafting

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Patients undergoing coronary artery bypass grafting, with or without cardiopulmonary bypass
Age ≥ 18

Exclusion Criteria

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone	52 weeks	Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo

Secondary Outcome Measures

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