Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · May 13, 2022

Keywords

ClinConnect Summary

The TOP-CABG trial is studying a treatment approach for patients who have undergone coronary artery bypass grafting (CABG), a surgery to improve blood flow to the heart. This trial is comparing two types of medications used to prevent blood clots: the standard dual antiplatelet therapy (DAPT) and a de-escalated version called de-DAPT. The goal is to see if the de-DAPT is just as effective in preventing problems with a specific type of graft, while also causing fewer bleeding complications.

To participate in this trial, you need to be between 18 and 80 years old and have surgery for the first time that involves at least one saphenous vein graft. However, there are several conditions that could prevent someone from joining, such as having certain heart conditions or taking specific medications. If you qualify, you will receive one of the two treatments and will be monitored for how well it works and any potential side effects. This trial is important because it aims to improve the safety and effectiveness of care for heart surgery patients.

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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
• • 1. Concomitant valve (excluding aortic bioprosthesis), aorta, or rhythm surgery during the same session.
• • 2. Patients undergo emergency CABG.
• • 3. Patients with single coronary artery disease.
• • 4. Patients with cardiogenic shock and hemodynamic instability.
• • 5. Patients with sick sinus syndrome, 2nd or 3rd atrioventricular block.
• • 6. Patients with contraindications for coronary computed tomography angiography or coronary angiography (eg. contrast allergy).
• • 7. 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.
• • 8. Patients who take oral anticoagulants before CABG and have to use anticoagulants after surgery.
• • 9. 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).
• • 10. 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
• • 11. Thrombocytopenia before CABG (\< 100 x 109/L).
• • 12. 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.
• • 13. Use of strong inhibitors of CYP3A4
• • 14. Patients who have to use methotrexate and ibuprofen.
• • 15. Patients with active malignant tumors with increase in bleeding risk in the investigator's opinion
• • 16. Pregnant patients, patients who have given birth within the past 90 days, or who are breastfeeding.
• • 17. 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.
• • 18. CABG volume of the surgeon less than 50.