NCT05380063CompletedPhase 4
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 in Patients Without Acute Coronary Syndrome
Source: ClinicalTrials.gov · Last updated 27 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2300 (actual)
- First submitted
- 13 May 2022
- Start date
- 14 Feb 2023
- Primary completion date
- 8 Jul 2025
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT05380063
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 2300
- From 14 Feb 2023 to the primary completion date, 8 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.