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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Antiplatelet Therapy (DAPT) | Active Comparator | DAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG. |
|
| De-escalated Dual Antiplatelet Therapy (De-DAPT) | Experimental | De-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During 0-day to 1-year after CABG |
| Bleeding events | Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG. | During 0-day to 1-year after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During 0-day to 1-year after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analysis 1 for primary outcome | Age (<65 years, ≥65 years) | 1 year |
| Subgroup analysis 2 for primary outcome | Sex (male, female) | 1 year |
Inclusion criteria
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
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| Name | Affiliation | Role |
|---|---|---|
| Shengshou Hu, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Xin Yuan, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Qing Chu, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Director |
| Kai Chen | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42120081 | Derived | 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. | |
| 37385747 |
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|
| Dual Antiplatelet Therapy | Drug | Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG. |
|
| Graft stenosis and occlusion | Significant (≥70%) venous or arterial graft stenosis and any (venous or arterial) graft occlusion | During 0-day to 1-year after CABG |
| 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 | Within 1-year after CABG |
| Subgroup analysis 3 for primary outcome | Body mass index (<25 kg/m2, ≥25 kg/m2) | 1 year |
| Subgroup analysis 4 for primary outcome | Acute Coronary Syndrome (yes, no) | 1 year |
| Subgroup analysis 5 for primary outcome | Hypertension (yes, no) | 1 year |
| Subgroup analysis 6 for primary outcome | Diabetes (yes, no) | 1 year |
| Subgroup analysis 7 for primary outcome | Dyslipidemia (yes, no) | 1 year |
| Subgroup analysis 8 for primary outcome | Prior myocardial infarction (yes, no) | 1 year |
| Subgroup analysis 9 for primary outcome | Current smoker (yes, no) | 1 year |
| Subgroup analysis 10 for primary outcome | Left ventricular ejection fraction (<50%, ≥50%) | 1 year |
| Subgroup analysis 11 for primary outcome | eGFR (<60/ml/min/1.75m2, ≥60/ml/min/1.75m2) | 1 year |
| Subgroup analysis 12 for primary outcome | Statin (yes, no) | 1 year |
| Subgroup analysis 13 for primary outcome | Beta-blocker (yes, no) | 1 year |
| Subgroup analysis 14 for primary outcome | RASi (yes, no) | 1 year |
| Subgroup analysis 15 for primary outcome | Off-pump (yes, no) | 1 year |
| Subgroup analysis 16 for primary outcome | Grafts (<3 , ≥3) | 1 year |
| Subgroup analysis 17 for primary outcome | Syntax score(≤22, 23-32 , ≥33) | 1 year |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006470 | Hemorrhage |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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