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NCT Number: NCT05380063

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Treatment and study plan

De-escalated Dual Antiplatelet Therapy

Drug

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.

Other names: De-escalation

Dual antiplatelet therapy

Drug

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

Primary outcomes

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

    Time frame: During 0-day to 1-year after CABG

    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

  2. Bleeding events

    Time frame: During 0-day to 1-year after CABG

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

Secondary outcomes

  1. SVG Failure

    Time frame: During 0-day to 1-year after CABG

    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

  2. Graft stenosis and occlusion

    Time frame: During 0-day to 1-year after CABG

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

  3. MACCE episodes

    Time frame: Within 1-year after CABG

    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

Other outcomes

  1. Subgroup analysis 1 for primary outcome

    Time frame: 1 year

    Age (<65 years, ≥65 years)

  2. Subgroup analysis 2 for primary outcome

    Time frame: 1 year

    Sex (male, female)

  3. Subgroup analysis 3 for primary outcome

    Time frame: 1 year

    Body mass index (<25 kg/m2, ≥25 kg/m2)

  4. Subgroup analysis 4 for primary outcome

    Time frame: 1 year

    Acute Coronary Syndrome (yes, no)

  5. Subgroup analysis 5 for primary outcome

    Time frame: 1 year

    Hypertension (yes, no)

  6. Subgroup analysis 6 for primary outcome

    Time frame: 1 year

    Diabetes (yes, no)

  7. Subgroup analysis 7 for primary outcome

    Time frame: 1 year

    Dyslipidemia (yes, no)

  8. Subgroup analysis 8 for primary outcome

    Time frame: 1 year

    Prior myocardial infarction (yes, no)

  9. Subgroup analysis 9 for primary outcome

    Time frame: 1 year

    Current smoker (yes, no)

  10. Subgroup analysis 10 for primary outcome

    Time frame: 1 year

    Left ventricular ejection fraction (<50%, ≥50%)

  11. Subgroup analysis 11 for primary outcome

    Time frame: 1 year

    eGFR (<60/ml/min/1.75m2, ≥60/ml/min/1.75m2)

  12. Subgroup analysis 12 for primary outcome

    Time frame: 1 year

    Statin (yes, no)

  13. Subgroup analysis 13 for primary outcome

    Time frame: 1 year

    Beta-blocker (yes, no)

  14. Subgroup analysis 14 for primary outcome

    Time frame: 1 year

    RASi (yes, no)

  15. Subgroup analysis 15 for primary outcome

    Time frame: 1 year

    Off-pump (yes, no)

  16. Subgroup analysis 16 for primary outcome

    Time frame: 1 year

    Grafts (<3 , ≥3)

  17. Subgroup analysis 17 for primary outcome

    Time frame: 1 year

    Syntax score(≤22, 23-32 , ≥33)

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: TOP-CABG

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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