Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07871591). StuddyBuddy aggregates publicly available trial information.