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One-Month DAPT in CABG Patients

One-Month DAPT in CABG Patients

Recruiting
18 years and older
All
Phase 3

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Overview

The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Description

A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Eligibility

Inclusion Criteria:

  • Age ≥18 years
  • Elective first-time CABG with use of ≥1 saphenous vein graft;
  • Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.

Exclusion Criteria:

  • Any indication for dual antiplatelet therapy, including
    • Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
    • Recent PCI requiring continuation of dual antiplatelet therapy after CABG
  • Current or anticipated use of oral anticoagulation;
  • Paroxysmal, persistent or permanent atrial fibrillation;
  • Any concomitant cardiac or non-cardiac procedure;
  • Planned cardiac or non-cardiac surgery within one year;
  • Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years;
  • Inability to use the saphenous vein;
  • Contraindications to the use of aspirin;
  • Contraindications to the use of ticagrelor, including
    • Known hypersensitivity to ticagrelor
    • Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
    • History of intracranial hemorrhage
    • Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
  • Inability to undergo coronary computed tomographic angiography (CCTA);
  • Participating in another investigational device or drug study;
  • Women of childbearing potential
  • Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.

Study details
    Chronic Coronary Disease

NCT05997693

Weill Medical College of Cornell University

15 October 2025

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