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Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

ConditionsCoronary Artery DiseaseCoronary Artery Bypass GraftingSaphenous VeinDual Antiplatelet Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKexiang Liu, MD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients 18-80 of age.

Patients undergo planned CABG for the first time with ≥1 SVGs

Patients with written informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • 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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: 3-Month DAPT GroupActive comparator 1 intervention
Group B: 6-Month DAPT GroupActive comparator 1 intervention
Group C: 12-Month DAPT GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Saphenous Vein Graft (SVG) Patency at 12 Months

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
12 months post-CABG

Secondary outcomes

1

Bleeding Events

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

Time frame
Up to 12 months post-CABG
2

MACCE episodes

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
Within 1-year after CABG
3

All-Cause Mortality

Death from any cause occurring during the study period.

Time frame
Up to 12 months post-CABG

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kexiang Liu, MD

Lead sponsor

Second Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: