TOP-CABG Trial: Follow-up Extension (TOP-CABG FE)

NCT07871591 — Not yet recruiting, 2290 participants, China National Center for Cardiovascular Diseases
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Extended Follow-up Study of the Efficacy and Safety of De-escalated Antiplatelet Therapy After Coronary Artery Bypass Grafting (TOP-CABG FE)

RegistryNCT07871591
StatusNot yet recruiting
Study typeObservational
Enrollment2290 (Estimated)
SponsorChina National Center for Cardiovascular Diseases (Other gov)
ConditionsCoronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding, Myocardial Ischemia, Myocardial Infarction
Datesstart 2026-10-15 (estimated), primary completion 2027-12-31 (estimated), completion 2028-06-30 (estimated), first posted 2026-10-13, last updated 2026-10-13

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-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.

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+Outcome measures

Primary outcomes

  • Four-point major adverse cardiovascular and cerebrovascular events (4P-MACCE) [Assessed at 3, 5, and 10 years.]: The composite of all-cause death, myocardial infarction, stroke, and coronary revascularization.

Secondary outcomes

  • Five-point major adverse cardiovascular and cerebrovascular events (5P-MACCE) [Assessed at 3, 5, and 10 years]: The composite of all-cause death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina
  • Three-point major adverse cardiovascular events (3P-MACE) [Assessed at 3, 5, and 10 years]: The composite of cardiovascular death, myocardial infarction, and stroke
  • Time to first occurrence of all-cause death [Assessed at 3, 5, and 10 years]
  • Time to first occurrence of cardiovascular death [Assessed at 3, 5, and 10 years]
  • Time to first occurrence of myocardial infarction [Assessed at 3, 5, and 10 years]
  • Time to first occurrence of stroke [Assessed at 3, 5, and 10 years]
  • Time to first occurrence of coronary revascularization [Assessed at 3, 5, and 10 years]
  • Time to first hospitalization for unstable angina [Assessed at 3, 5, and 10 years]
  • Other cardiovascular hospitalizations [Assessed at 3, 5, and 10 years]
  • Quality of life, assessed using the Seattle Angina Questionnaire (SAQ) [Assessed at 3, 5, and 10 years]
  • Quality of life, assessed using the 12-Item Short Form Health Survey (SF-12) [Assessed at 3, 5, and 10 years]
  • Quality of life, assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) [Assessed at 3, 5, and 10 years]
  • Depressive symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9) [Assessed at 3, 5, and 10 years]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.