Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

Sponsor
Kexiang Liu, MD
Study ID
NCT06981390
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
May 20, 2025
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Feb 20, 2027
Completion
Mar 20, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 3-Month DAPT Group
    Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy
  • Active Comparator: 6-Month DAPT Group
    Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy
  • Experimental: 12-Month DAPT Group
    Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy

Primary Outcome Measure

Saphenous Vein Graft (SVG) Patency at 12 Months [ Time Frame: 12 months post-CABG ]

Central Contacts

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