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NCT07871591
TOP-CABG Trial: Follow-up Extension (TOP-CABG FE)
Conditions: Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding, Myocardial Ischemia, Myocardial Infarction
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 2290
Sponsor: China National Center for Cardiovascular Diseases
Summary
To further evaluate the long-term effects of the two antiplatelet strategies on saphenous vein graft patency, long-term adverse cardiovascular events, and bleeding events after coronary artery bypass grafting (CABG), we plan to conduct an extended follow-up study based on the previously completed TOP-CABG trial. This extended follow-up aims to provide high-quality evidence to inform more optimized and individualized long-term antiplatelet management strategies for patients after CABG.
Eligibility Criteria
Inclusion criteria
* Patients 18-80 of age.
* Patients undergo planned CABG for the first time with ≥1 SVGs
* Patients with written informed consent.
Exclusion criteria
* Concomitant valve (excluding aortic bioprosthesis), aorta, or rhythm surgery during the same session.
* Patients undergo emergency CABG.
* Patients with single coronary artery disease.
* Patients with cardiogenic shock and hemodynamic instability.
* Patients with sick sinus syndrome, 2nd or 3rd atrioventricular block.
* Patients with contraindications for coronary computed tomography angiography or coronary angiography (eg. contrast allergy).
* Use of other antiplatelet drugs than aspirin or ticagrelor (clopidogrel, prasugrel, etc) and unable to discontinue this medication after CABG, in the treating physician's or the investigator's opinion.
* Patients who take oral anticoagulants before CABG and have to use anticoagulants after surgery.
* Contraindication for the use of ticagrelor or aspirin (ie. history of bleeding diathesis within 3 months prior presentation, severe gastrointestinal bleeding within 1year prior presentation, peptic ulcer without gastrointestinal bleeding in past 3 years or history of intracranial hemorrhage, allergy, severe gastrointestinal reaction caused by aspirin).
* Placement of a drug-eluting stent in a coronary or cerebral artery within 6 months of CABG or placement of a bare-metal stent in a coronary or cerebral artery within 1 month of CABG
* Thrombocytopenia before CABG (\< 100 x 109/L).
* Patients with severe renal function impairment requiring dialysis or active liver disease, including patients with unexplained persistent elevated transaminase or any transaminase more than 3 times the normal limit.
* Use of strong inhibitors of CYP3A4
* Patients who have to use methotrexate and ibuprofen.
* Patients with active malignant tumors with increase in bleeding risk in the investigator's opinion
* Pregnant patients, patients who have given birth within the past 90 days, or who are breastfeeding.
* Premenopausal women who do not take adequate contraception. Adequate contraception refers to the adoption of at least two reliable methods of contraception, one of which must be a barrier method of contraception.
* CABG volume of the surgeon less than 50.
Source: ClinicalTrials.gov (NCT07871591). StuddyBuddy aggregates publicly available trial information.