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NCT Number: NCT06981390

Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location contact

kexiang liu, Ph.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18-80 of age.
  • Patients undergo planned CABG for the first time with ≥1 SVGs
  • Patients with written informed consent.

Exclusion criteria

  • Patients undergoing concomitant valve surgery (excluding aortic bioprosthesis), aortic surgery, or rhythm surgery during the same session.
  • Patients undergoing emergency CABG.
  • Patients with single-vessel coronary artery disease.
  • Patients with cardiogenic shock or hemodynamic instability.
  • Patients with sick sinus syndrome, second- or third-degree atrioventricular block.
  • Patients with contraindications for coronary computed tomography angiography (CCTA) or coronary angiography, including contrast media allergy.
  • Patients requiring antiplatelet therapy other than aspirin or ticagrelor (e.g., clopidogrel, prasugrel) and unable to discontinue such medication after CABG, based on physician or investigator judgment.
  • Patients on oral anticoagulants before CABG who must continue anticoagulation therapy postoperatively.
  • Patients with contraindications for ticagrelor or aspirin, including:

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.

  • Patients with a drug-eluting stent (DES) in a coronary or cerebral artery within 6 months before CABG, or a bare-metal stent (BMS) within 1 month before CABG.
  • Patients with thrombocytopenia (<100 x 10⁹/L) before CABG.
  • Patients with severe renal dysfunction requiring dialysis or active liver disease, including unexplained persistent transaminase elevation or transaminase levels >3× the upper normal limit.
  • Patients using strong CYP3A4 inhibitors.
  • Patients requiring methotrexate and ibuprofen therapy.
  • Patients with active malignant tumors with an increased risk of bleeding, as determined by the investigator.
  • Pregnant or breastfeeding women, and those who have given birth within the past 90 days.
  • Premenopausal women not using adequate contraception. Adequate contraception requires at least two reliable methods, including one barrier method.

Treatment and study plan

Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)

Drug

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy

Other names: 3-Month DAPT

Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)

Drug

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy

Other names: 6-Month DAPT

Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)

Drug

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy

Other names: 12-Month DAPT

Primary outcomes

  1. Saphenous Vein Graft (SVG) Patency at 12 Months

    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).

Secondary outcomes

  1. Bleeding Events

    Time frame: Up to 12 months post-CABG

    Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.

  2. MACCE episodes

    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

  3. All-Cause Mortality

    Time frame: Up to 12 months post-CABG

    Death from any cause occurring during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

kexiang liu

CONTACT

[email protected]

17390920328

Sponsors and collaborators

Lead sponsor

Kexiang Liu, MD

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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