NCT06981390

Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

Ticagrelor-Based Dual Antiplatelet Therapy in Coronary Artery Bypass Grafting: A Randomized Clinical Trial on Graft Patency

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Kexiang Liu, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial aims to evaluate the impact of different durations of Ticagrelor-based dual antiplatelet therapy (DAPT) on saphenous vein graft (SVG) patency in patients undergoing coronary artery bypass grafting (CABG). A total of 300 patients will be randomly assigned to receive Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, 6 months, or 12 months, followed by aspirin monotherapy.The primary outcome is 1-year graft patency, assessed via coronary CT angiography. Secondary outcomes include bleeding events (BARC classification), major adverse cardiovascular and cerebrovascular events (MACCE), and all-cause mortality. The study aims to determine the optimal DAPT duration to balance graft patency benefits and bleeding risks, ultimately guiding postoperative antiplatelet strategies for CABG patients.

Detailed description

Coronary artery bypass grafting (CABG) is a widely used revascularization strategy for patients with complex coronary artery disease. However, the long-term patency of saphenous vein grafts (SVGs) remains a significant clinical concern, with graft occlusion being a major contributor to recurrent ischemic events. Dual antiplatelet therapy (DAPT), consisting of Ticagrelor and Aspirin, is commonly used to prevent thrombosis and improve graft patency, yet the optimal duration of DAPT post-CABG remains unclear. This randomized, double-blind, controlled trial aims to assess the effects of different DAPT durations on SVG patency and clinical outcomes in CABG patients. A total of 300 patients undergoing isolated CABG with at least one SVG will be enrolled and randomly assigned (1:1:1) to receive Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, 6 months, or 12 months, followed by aspirin monotherapy. The primary outcome of the study is SVG patency at 12 months, assessed via coronary CT angiography, defined as FitzGibbon Grade A (≤50% stenosis). Secondary outcomes include bleeding events , major adverse cardiovascular and cerebrovascular events (MACCE), and all-cause mortality. Patients will be followed at 3, 6, and 12 months postoperatively, undergoing clinical assessments, laboratory tests, and imaging evaluations to monitor graft patency, bleeding complications, and cardiovascular and cerebrovascular events. The study will provide critical data to determine the optimal duration of DAPT to maximize graft patency while minimizing bleeding risks, ultimately guiding personalized antiplatelet strategies in CABG patients.

Conditions

• Coronary Artery Disease
• Coronary Artery Bypass Grafting
• Saphenous Vein
• Dual Antiplatelet Therapy

Interventions

Type	Name	Description
DRUG	Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)	Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy
DRUG	Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)	Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy
DRUG	Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)	Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-20
• Completion: 2026-03-20
• First posted: 2025-05-20
• Last updated: 2025-07-23

Locations

1 site across 1 country: China