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NCT Number: NCT05997693

One-Month DAPT in CABG Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ticagrelor 90 MG

Drug

Ticagrelor 90 mg twice daily taken orally for one month

Low-dose aspirin

Drug

75-150 mg once daily taken orally

Primary outcomes

  1. Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.

    Time frame: 1 year

    This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:

    • Time to all-cause mortality
    • Time to stroke
    • Time to myocardial infarction
    • Time to coronary revascularization
    • Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month

Secondary outcomes

  1. Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.

    Time frame: 1 year

    This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:

    • Time to all-cause mortality
    • Time to stroke
    • Time to myocardial infarction
    • Time to BARC 3 bleeding
    • Time to coronary revascularization
    • Presence of graft failure at 12-month imaging follow-up
  2. Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score

    Time frame: 5 years

    This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:

    • Time to all-cause mortality
    • Time to stroke
    • Time to myocardial infarction
    • Time to coronary revascularization
    • 5-year time-averaged disease-specific QOL (SAQ-7) score
  3. Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.

    Time frame: 5 years

    This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:

    • Time to all-cause mortality
    • Time to stroke
    • Time to myocardial infarction
    • Time to BARC 3 bleeding
    • Time to coronary revascularization
    • 5-year time-averaged disease-specific QOL (SAQ-7) score

Study contacts

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

Trisha Ali-Shaw

CONTACT

[email protected]

646-962-8281

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients

Acronym: ODIN

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Aug 18, 2023
Registry last updated
Dec 22, 2025

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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