Coronary Graft Patency | Aspirin and Plavix Following Coronary Artery Bypass Grafting
Coronary Graft Patency research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Coronary Graft Patency
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:clopidogrelclopidogrel 75mg daily by mouth daily for 12 months
Drug:sugar pillsugar pill by mouth daily for 12 months
Drug:Aspirinaspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
clopidogrelaspirin and clopidogrel
sugar pillaspirin and placebo
Start Date: July 2010
Completed Date: December 2014
Phase: Phase 4
Primary Outcome: Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone
Secondary Outcome: Incidence of Bleeding Between the Two Treatment Arms
Study sponsors, principal investigator, and references
Principal Investigator: Ahmad M Slim, MD
Lead Sponsor: Ahmad Slim
Collaborator: Bristol-Myers Squibb