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 in Patients Without Acute Coronary Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,300 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Coronary Artery Disease
• Coronary Artery Bypass Grafting
• Dual Antiplatelet Therapy
• Bleeding
• Myocardial Infarction
• Myocardial Ischemia
• Angina Pectoris

Interventions

Type	Name	Description
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.
DRUG	Dual Antiplatelet Therapy	Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG.

Timeline

• Start date: 2023-02-14
• Primary completion: 2025-07-08
• Completion: 2025-07-10
• First posted: 2022-05-18
• Last updated: 2025-08-27

Locations

1 site across 1 country: China