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

Phase 4

Recruiting

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

Interventions: Drug: Dual Antiplatelet Therapy
Drug: De-escalated Dual Antiplatelet Therapy

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.

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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Dual Antiplatelet Therapy (DAPT)	Dual Antiplatelet Therapy	DAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG.
De-escalated Dual Antiplatelet Therapy (De-DAPT)	De-escalated Dual Antiplatelet Therapy	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.

Primary Outcome Measures

Name	Time	Method
100% great saphenous vein (SVG) grafts occlusions	During 0-day to 1-year after CABG	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
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

Name	Time	Method
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
MACCE episodes	Within 1-year after CABG	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
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