the Second Hospital of Jilin University
Changchun, Jilin, 130000, China
Location contact
kexiang liu, Ph.D.
CONTACT
NCT Number: NCT06981390
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Changchun, Jilin, 130000, China
kexiang liu, Ph.D.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
9.1Bleeding diathesis within the past 3 months. 9.2Severe gastrointestinal bleeding within the past year. 9.3Peptic ulcer (even without bleeding) within the past 3 years. 9.4History of intracranial hemorrhage, aspirin allergy, or severe aspirin-induced gastrointestinal reaction.
Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy
Other names: 3-Month DAPT
Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy
Other names: 6-Month DAPT
Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy
Other names: 12-Month DAPT
Time frame: 12 months post-CABG
SVG patency will be assessed using coronary CT angiography, defined as FitzGibbon Grade A (≤50% stenosis). The patency rates will be compared among the three groups receiving Ticagrelor-based DAPT for different durations (3 months, 6 months, or 12 months).
Time frame: Up to 12 months post-CABG
Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.
Time frame: 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
Time frame: Up to 12 months post-CABG
Death from any cause occurring during the study period.
Contact information is provided by the study sponsor or research team.
Kexiang Liu, MD
Other
Ticagrelor-Based Dual Antiplatelet Therapy in Coronary Artery Bypass Grafting: A Randomized Clinical Trial on Graft Patency
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