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Not yet recruitingNCT07871591Updated Oct 13, 2026

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

An observational study in Coronary Artery Disease, Coronary Artery Bypass Grafting and Dual Antiplatelet Therapy, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by China National Center for Cardiovascular Diseases · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,290
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
  • Coronary Artery Bypass Grafting
  • Dual Antiplatelet Therapy
  • Bleeding
  • Myocardial Ischemia
  • Myocardial Infarction
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 2,290 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 262 studies on the registry; 138 are open to participants now.

Browse China National Center for Cardiovascular Diseases studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,290 participants (estimated)
Patient registry
No
06

What researchers measure

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

  5. Time to first occurrence of myocardial infarction

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

  6. Time to first occurrence of stroke

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

  7. Time to first occurrence of coronary revascularization

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

  8. Time to first hospitalization for unstable angina

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

  9. Other cardiovascular hospitalizations

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

  10. Quality of life, assessed using the Seattle Angina Questionnaire (SAQ)

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

  11. Quality of life, assessed using the 12-Item Short Form Health Survey (SF-12)

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

  12. Quality of life, assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)

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

  13. Depressive symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9)

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

Of 726 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 14 months is below that.

Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871591
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Shengshou Hu (Principal Investigator, China National Center for Cardiovascular Diseases) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Xin Yuan, MD, PhD
Contact
yuanxinfuwai@163.com
+86 010 60866780

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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