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

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05380063

Collaborator

(none)

2,300

Enrollment

Location

Arms

Anticipated Duration (Months)

63.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Artery Bypass Grafting Dual Antiplatelet Therapy Bleeding Myocardial Infarction Myocardial Ischemia Angina Pectoris	Drug: De-escalated Dual Antiplatelet Therapy Drug: Dual Antiplatelet Therapy	Phase 4

Detailed Description

After informed consent, 11 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 Design

Study Type:

Interventional

Anticipated Enrollment :

2300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

100% great saphenous vein (SVG) grafts occlusions [During 7-day to 1-year after CABG]
100% SVG during 7-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
Bleeding events [During 0-day to 1-year after CABG]
Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.

Secondary Outcome Measures

100% SVG occlusions during 7-day after CABG (Fitz Gibbon grade O). [During 7-day after CABG]
100% SVG occlusions during 7-day 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
SVG Failure [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
Graft stenosis and occlusion [During 0-day to 1-year after CABG]
Significant (≥70%) venous or arterial graft stenosis and any (venous or arterial) graft occlusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who underwent planned isolated CABG with ≥1 SVGs were eligible for inclusion

Exclusion Criteria:

1. Patients who underwent valvular surgery, arrhythmia and other cardiac operations at the same time as CABG surgery.

Acute coronary syndrome (ACS) patients. 3) patients with contraindications of multislice computed tomographic angiography or coronary angiography.
patients who take oral anticoagulants before operation and need to continue to take anticoagulants after operation.
patients who take oral P2Y12 inhibitors or other antiplatelet drugs before operation and cannot stop the drugs after operation.
patients with contraindications to antiplatelet therapy (history of allergy, intracranial hemorrhage, massive hemorrhage, gastrointestinal reactions caused by intolerance to antiplatelet drugs).
patients with implanted eluting stents within 6 months or bare metal stents within 1 month before CABG.
Thrombocytopenia before CABG