Coronary Artery DiseaseNCT07871591
TOP-CABG Trial: Follow-up Extension (TOP-CABG FE)
An observational study of Coronary Artery Disease and Coronary Artery Bypass Grafting, run by China National Center for Cardiovascular Diseases.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy
- How many people
- 2,290 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Patients 18-80 of age.
- Patients undergo planned CABG for the first time with ≥1 SVGs
- Patients with written informed consent.
Who cannot join
- 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).
Show all 18Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Extended Follow-up Study of the Efficacy and Safety of De-escalated Antiplatelet Therapy After Coronary Artery Bypass Grafting (TOP-CABG FE)
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.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding, Myocardial Ischemia, Myocardial Infarction
- Medical subject headings
- Coronary Artery Disease, Hemorrhage, Myocardial Ischemia, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Four-point major adverse cardiovascular and cerebrovascular events (4P-MACCE)
The composite of all-cause death, myocardial infarction, stroke, and coronary revascularization.
Measured: Assessed at 3, 5, and 10 years.
Secondary outcomes (13)
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
Measured: Assessed at 3, 5, and 10 years
Three-point major adverse cardiovascular events (3P-MACE)
The composite of cardiovascular death, myocardial infarction, and stroke
Measured: Assessed at 3, 5, and 10 years
Time to first occurrence of all-cause death
Measured: Assessed at 3, 5, and 10 years
Time to first occurrence of cardiovascular death
Measured: Assessed at 3, 5, and 10 years
Time to first occurrence of myocardial infarction
Measured: Assessed at 3, 5, and 10 years
Time to first occurrence of stroke
Measured: Assessed at 3, 5, and 10 years
Time to first occurrence of coronary revascularization
Measured: Assessed at 3, 5, and 10 years
Time to first hospitalization for unstable angina
Measured: Assessed at 3, 5, and 10 years
Other cardiovascular hospitalizations
Measured: Assessed at 3, 5, and 10 years
Quality of life, assessed using the Seattle Angina Questionnaire (SAQ)
Measured: Assessed at 3, 5, and 10 years
Quality of life, assessed using the 12-Item Short Form Health Survey (SF-12)
Measured: Assessed at 3, 5, and 10 years
Quality of life, assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Measured: Assessed at 3, 5, and 10 years
Depressive symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9)
Measured: Assessed at 3, 5, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,290 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shengshou Hu, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871591
- Sponsor's protocol ID
- 2026-ZX134
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Follow-up Study of the Efficacy and Safety of De-escalated Antiplatelet Therapy After Coronary Artery Bypass Grafting (TOP-CABG FE)
- ClinicalTrials.gov ID
- NCT07871591
- Acronym / sponsor ID
- 2026-ZX134
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding, Myocardial Ischemia, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,290 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Patients 18-80 of age.
- Patients undergo planned CABG for the first time with ≥1 SVGs
- Patients with written informed consent.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Four-point major adverse cardiovascular and cerebrovascular events (4P-MACCE)
Time frame: Assessed at 3, 5, and 10 years.
The composite of all-cause death, myocardial infarction, stroke, and coronary revascularization.
13 secondary outcomes
Five-point major adverse cardiovascular and cerebrovascular events (5P-MACCE)
Time frame: Assessed at 3, 5, and 10 years
Three-point major adverse cardiovascular events (3P-MACE)
Time frame: Assessed at 3, 5, and 10 years
Time to first occurrence of all-cause death
Time frame: Assessed at 3, 5, and 10 years
Time to first occurrence of cardiovascular death
Time frame: Assessed at 3, 5, and 10 years
Time to first occurrence of myocardial infarction
Time frame: Assessed at 3, 5, and 10 years
Time to first occurrence of stroke
Time frame: Assessed at 3, 5, and 10 years
Time to first occurrence of coronary revascularization
Time frame: Assessed at 3, 5, and 10 years
Time to first hospitalization for unstable angina
Time frame: Assessed at 3, 5, and 10 years
Other cardiovascular hospitalizations
Time frame: Assessed at 3, 5, and 10 years
Quality of life, assessed using the Seattle Angina Questionnaire (SAQ)
Time frame: Assessed at 3, 5, and 10 years
Quality of life, assessed using the 12-Item Short Form Health Survey (SF-12)
Time frame: Assessed at 3, 5, and 10 years
Quality of life, assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: Assessed at 3, 5, and 10 years
Depressive symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Assessed at 3, 5, and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Artery Bypass Grafting, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Yuan, MD, PhD (+86 010 60866780, yuanxinfuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four-point major adverse cardiovascular and cerebrovascular events (4P-MACCE) (time frame: Assessed at 3, 5, and 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.