Status:
COMPLETED
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Coronary Artery Disease
Coronary Artery Bypass Grafting
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlle...
Detailed Description
After informed consent, at least 10 centers and 2,300 eligible admissions will be recruited. Eligible patients would be randomized (1:1) in double-blind manner (patients and treating physicians) to du...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 1\. Patients 18-80 of age. 2. Patients undergo planned CABG for the first time with ≥1 SVGs 3. 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.
Exclusion
Key Trial Info
Start Date :
February 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
2300 Patients enrolled
Trial Details
Trial ID
NCT05380063
Start Date
February 14 2023
End Date
July 10 2025
Last Update
August 27 2025
Active Locations (1)
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1
Fuwai Hospital
Beijing, China