Status:
RECRUITING
Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG
Lead Sponsor:
Kexiang Liu, MD
Conditions:
Coronary Artery Disease
Coronary Artery Bypass Grafting
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This randomized controlled trial aims to evaluate the impact of different durations of Ticagrelor-based dual antiplatelet therapy (DAPT) on saphenous vein graft (SVG) patency in patients undergoing co...
Detailed Description
Coronary artery bypass grafting (CABG) is a widely used revascularization strategy for patients with complex coronary artery disease. However, the long-term patency of saphenous vein grafts (SVGs) rem...
Eligibility Criteria
Inclusion
- Patients 18-80 of age.
- Patients undergo planned CABG for the first time with ≥1 SVGs
- Patients with written informed consent.
Exclusion
- Patients undergoing concomitant valve surgery (excluding aortic bioprosthesis), aortic surgery, or rhythm surgery during the same session.
- Patients undergoing emergency CABG.
- Patients with single-vessel coronary artery disease.
- Patients with cardiogenic shock or hemodynamic instability.
- Patients with sick sinus syndrome, second- or third-degree atrioventricular block.
- Patients with contraindications for coronary computed tomography angiography (CCTA) or coronary angiography, including contrast media allergy.
- Patients requiring antiplatelet therapy other than aspirin or ticagrelor (e.g., clopidogrel, prasugrel) and unable to discontinue such medication after CABG, based on physician or investigator judgment.
- Patients on oral anticoagulants before CABG who must continue anticoagulation therapy postoperatively.
- Patients with contraindications for ticagrelor or aspirin, including:
- 1Bleeding diathesis within the past 3 months. 9.2Severe gastrointestinal bleeding within the past year. 9.3Peptic ulcer (even without bleeding) within the past 3 years. 9.4History of intracranial hemorrhage, aspirin allergy, or severe aspirin-induced gastrointestinal reaction.
- Patients with a drug-eluting stent (DES) in a coronary or cerebral artery within 6 months before CABG, or a bare-metal stent (BMS) within 1 month before CABG.
- Patients with thrombocytopenia (\<100 x 10⁹/L) before CABG.
- Patients with severe renal dysfunction requiring dialysis or active liver disease, including unexplained persistent transaminase elevation or transaminase levels \>3× the upper normal limit.
- Patients using strong CYP3A4 inhibitors.
- Patients requiring methotrexate and ibuprofen therapy.
- Patients with active malignant tumors with an increased risk of bleeding, as determined by the investigator.
- Pregnant or breastfeeding women, and those who have given birth within the past 90 days.
- Premenopausal women not using adequate contraception. Adequate contraception requires at least two reliable methods, including one barrier method.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06981390
Start Date
February 1 2025
End Date
March 20 2026
Last Update
July 23 2025
Active Locations (1)
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1
the Second Hospital of Jilin University
Changchun, Jilin, China, 130000