Comparison of aspirin versus aspirin plus clopidogrel for prevention of saphenous vein graft occlusion following coronary artery bypass grafting.
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003991
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
1) Men or women at least 18 years of age
2) Patients undergoing CABG with the use of 1 or more SVGs
3) The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
1) A known intolerance to a study drug (aspirin, clopidogrel)
2) Patients who will have valve or aorta surgery simultaneously.
3) History of hemorrhagic stroke or known structural cerebral vascular lesion (AV malformation, aneurysm, etc)
4) Patients requiring long-term oral anticoagulants or dual antiplatelet therapy
5) Persistent thrombocytopenia (platelet count <100,000/?l)
6) Chronic kidney disease (eGFR<30ml/min/1.73m2)
7) Inability to undergo coronary computed tomography angiography, in the investigator's opinion, for instance due to severe claustrophobia or contrast allergy
8) Current treatment for the active cancer
9) Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
10)Unwillingness or inability to comply with the procedures described in this protocol.
11) Patient’s pregnant or breast-feeding or child-bearing potential.
12) Patients who had CPCR due to cardiac arrest or ECHMO due to critical heart failure
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of occlusion of SVG using Coronary artery CT at the time of 12months after the randomization.
- Secondary Outcome Measures
Name Time Method The incidence of non-fatal MI, Stroke, coronary induced death within 12months after the randomization.;All-cause death and revascularization within 12months after the randomization.;Bleeding classified by Thrombolysis In Myocardial Infarction (TIMI) within 12months after the randomization.