Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting (TOP-CABG)
Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass Grafting, Ticagrelor, Aspirin, Dual Antiplatelet Therapy, De-escalated Dual Antiplatelet Therapy, Great Saphenous Vein, Bleeding
Eligibility Criteria
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.
Sites / Locations
- Fuwai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Dual Antiplatelet Therapy (DAPT)
De-escalated Dual Antiplatelet Therapy (De-DAPT)
DAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG.
De-DAPT referred to ticagrelor (90mg twice daily) + aspirin (100 mg once daily) during first 3 months post CABG, then switch to aspirin (100 mg once daily) + placebo (twice daily) for 9 months.