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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18-80 of age.

Patients undergo planned CABG for the first time with ≥1 SVGs

Patients with written informed consent.

Disqualifiers

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.

Trial population

The study population consists of participants previously enrolled in the TOP-CABG trial who underwent coronary artery bypass grafting (CABG) with at least one saphenous vein graft and were randomized to either 3-month dual antiplatelet therapy or 12-month dual antiplatelet therapy. Participants who completed the original trial and are eligible for extended follow-up will be included to assess long-term graft-related outcomes, cardiovascular events, bleeding events, quality of life, and other patient-reported outcomes.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Four-point major adverse cardiovascular and cerebrovascular events (4P-MACCE)

The composite of all-cause death, myocardial infarction, stroke, and coronary revascularization.

Time frame
Assessed at 3, 5, and 10 years.

Secondary outcomes

1

Five-point major adverse cardiovascular and cerebrovascular events (5P-MACCE)

The composite of all-cause death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina

Time frame
Assessed at 3, 5, and 10 years
2

Three-point major adverse cardiovascular events (3P-MACE)

The composite of cardiovascular death, myocardial infarction, and stroke

Time frame
Assessed at 3, 5, and 10 years
3

Time to first occurrence of all-cause death

Time frame
Assessed at 3, 5, and 10 years
4

Time to first occurrence of cardiovascular death

Time frame
Assessed at 3, 5, and 10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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