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Coronary Artery DiseasePhase 4TOP-CABGNCT05380063

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

A Phase 4 study testing De-escalated Dual Antiplatelet Therapy and Dual Antiplatelet Therapy in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlled trial. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
De-escalated Dual Antiplatelet Therapy and Dual Antiplatelet Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,300 participants
Where
1 siteChina
Study dates
14 Feb 2023to 10 Jul 2025
Phase
Phase 4
Are there results?
None posted in the registry

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

Who may be able to join

  • 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
  • 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.
Show all 19Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital

    Beijing

Other trials in China

About this study

Official title: Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting in Patients Without Acute Coronary Syndrome

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlled trial. The aim of TOP-CABG is to investigate whether de-escalated dual antiplatelet therapy (De-DAPT) is non-inferior to dual antiplatelet therapy (DAPT) in efficacy on inhibiting great saphenous vein (SVG) graft occlusion and is superior in reducing bleeding events in patients accepting coronary artery bypassing grafting.

Read the detailed description

After informed consent, at least 10 centers and 2,300 eligible admissions will be recruited. Eligible patients would be randomized (1:1) in double-blind manner (patients and treating physicians) to dual antiplatelet therapy (DAPT) group (ticagrelor 90mg bid and aspirin 100 mg qd for 12 month) and de-escalated DAPT (De-DAPT) group (90mg bid and aspirin 100 mg qd for first 3 months, and then aspirin 100 mg qd and placebo for 9 months).

Being tested
De-escalated Dual Antiplatelet Therapy, Dual Antiplatelet Therapy
Keywords
Coronary Artery Bypass Grafting, Ticagrelor, Aspirin, Dual Antiplatelet Therapy, De-escalated Dual Antiplatelet Therapy, Great Saphenous Vein, Bleeding
Medical subject headings
Coronary Artery Disease, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • De-escalated Dual Antiplatelet TherapyDrug

    Also called De-escalation

    ticagrelor (90mg twice daily) + aspirin (100 mg once daily) during first 3 months post CABG, then switching to aspirin (100 mg once daily) + placebo (twice daily) for 9 months.

  • Dual Antiplatelet TherapyDrug

    Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG.

Study groups in NCT05380063
Study groupRoleWhat they receive
Dual Antiplatelet Therapy (DAPT)Active comparatorDAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG.
Receives: Drug: Dual Antiplatelet Therapy
De-escalated Dual Antiplatelet Therapy (De-DAPT)ExperimentalDe-DAPT referred to ticagrelor (90mg twice daily) + aspirin (100 mg once daily) during first 3 months post CABG, then switch to aspirin (100 mg once daily) + placebo (twice daily) for 9 months.
Receives: Drug: De-escalated Dual Antiplatelet Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 100% great saphenous vein (SVG) grafts occlusions

    100% SVG During 0-day to 1-year after CABG (Fitz Gibbon grade O). SVG grafts were assessed by multislice computed tomographic angiography or coronary angiography and interpreted by an independent Image Data Review Centre blinded to treatment allocation

    Measured: During 0-day to 1-year after CABG

  2. Bleeding events

    Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.

    Measured: During 0-day to 1-year after CABG

Secondary outcomes (3)

  1. SVG Failure

    a composite of SVG occlusion in any SVG as defined above, SVG revascularization, myocardial infarction in myocardial territory supplied by an SVG, or sudden death, as defined by the American College of Cardiology and American Heart Association and judged by an independent Clinical Endpoint Committee blinded to treatment allocation

    Measured: During 0-day to 1-year after CABG

  2. Graft stenosis and occlusion

    Significant (≥70%) venous or arterial graft stenosis and any (venous or arterial) graft occlusion

    Measured: During 0-day to 1-year after CABG

  3. MACCE episodes

    MACCE episodes within 1-year after CABG (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or revascularization), as defined by the American College of Cardiology and American Heart Association and judged by an independent Clinical Endpoint Committee blinded to treatment allocation

    Measured: Within 1-year after CABG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start14 Feb 2023
  3. Primary completion8 Jul 2025
  4. Study completion10 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05380063
Sponsor's protocol ID
2022-ZX100
Acronym
TOP-CABG
Status last verified
Jul 2025
First submitted
13 May 2022
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuan X, Li J, Lei L, Zhang L, Chen K, Chu Q, Feng W, Wang X, Wang X, Xu F, Liu S, Yang Y, Wang X, Wang H, Dong A, Cheng Z, Guo H, Zhou T, Chen X, Ge J, Zhang L, Liu S, Shen Z, Wang J, Wang Y, Li W, Hu S; TOP-CABG Collaborative Group. Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial. BMJ. 2026 May 12;393:e088939. doi: 10.1136/bmj-2025-088939.

    PubMed 42120081

  • Yuan X, Chu Q, Chen K, Wang Y, Zhang L, Zheng Y, Hu S. Multicentre, randomised, double-blind, parallel controlled trial to investigate timing of platelet inhibition after coronary artery bypass grafting: TOP-CABG trial study. BMJ Open. 2023 Jun 29;13(6):e070823. doi: 10.1136/bmjopen-2022-070823.

    PubMed 37385747

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing De-escalated Dual Antiplatelet Therapy and Dual Antiplatelet Therapy in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by China National Center for Cardiovascular Diseases at 1 site in China.

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 19 inclusion and 0 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: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

100% great saphenous vein (SVG) grafts occlusions (time frame: During 0-day to 1-year after CABG). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05380063, which also lists 2 linked publications.

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 27 Aug 2025.

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