Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting (TOP-CABG)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Bleeding; Angina Pectoris; Dual Antiplatelet Therapy; Coronary Artery Bypass Grafting
• Intervention / Treatment: Drug: Dual Antiplatelet Therapy; Drug: De-escalated Dual Antiplatelet Therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 2300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

1. Concomitant valve (excluding aortic bioprosthesis), aorta, or rhythm surgery during the same session.
2. Patients undergo emergency CABG.
3. Patients with single coronary artery disease.
4. Patients with cardiogenic shock and hemodynamic instability.
5. Patients with sick sinus syndrome, 2nd or 3rd atrioventricular block.
6. Patients with contraindications for coronary computed tomography angiography or coronary angiography (eg. contrast allergy).
7. 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.
8. Patients who take oral anticoagulants before CABG and have to use anticoagulants after surgery.
9. 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).
10. 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
11. Thrombocytopenia before CABG (< 100 x 109/L).
12. 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.
13. Use of strong inhibitors of CYP3A4
14. Patients who have to use methotrexate and ibuprofen.
15. Patients with active malignant tumors with increase in bleeding risk in the investigator's opinion
16. Pregnant patients, patients who have given birth within the past 90 days, or who are breastfeeding.
17. 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.
18. CABG volume of the surgeon less than 50.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dual Antiplatelet Therapy (DAPT); DAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG.	Drug: Dual Antiplatelet Therapy; Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG.
Experimental: De-escalated Dual Antiplatelet Therapy (De-DAPT); 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.	Drug: De-escalated Dual Antiplatelet Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Shengshou Hu, MD, Chinese Academy of Medical Sciences, Fuwai Hospital; Study Chair: Xin Yuan, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital; Study Director: Qing Chu, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital; Study Director: Kai Chen, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): July 8, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Ticagrelor; Aspirin; Bleeding; Dual Antiplatelet Therapy; Coronary Artery Bypass Grafting; Great Saphenous Vein; De-escalated Dual Antiplatelet Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Artery Disease; Myocardial Ischemia; Hemorrhage; Myocardial Infarction; Angina Pectoris
• Other Study ID Numbers: 2022-ZX100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No