One-Month DAPT in CABG Patients (ODIN)

December 19, 2025 updated by: Weill Medical College of Cornell University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University Graz
        • Contact:
        • Principal Investigator:
          • Günther Laufer, MD
      • Linz, Austria
        • Recruiting
        • Johannes Kepler University Linz
        • Principal Investigator:
          • Andreas Zierer
        • Contact:
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Sigrid Sandner, MD, MSCE
        • Contact:
    • Innsbruck
      • Innsbruck, Innsbruck, Austria, 6020
        • Recruiting
        • Medical University Innsbruck
        • Principal Investigator:
          • Elfriede Ruttmann-Ulmer
        • Contact:
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Not yet recruiting
        • University of Ottawa Heart Institute
        • Contact:
        • Principal Investigator:
          • Marc Ruel, MD, MPH
  • China
      • Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
        • Principal Investigator:
          • Ran Dong
      • Beijing, China
        • Recruiting
        • Center China Fuwai Hospital
        • Contact:
        • Principal Investigator:
          • Zhaoyun Cheng
    • China
      • Shanghai, China, China, 200023
        • Recruiting
        • Ruijin Hospital: Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Qiang Zhao, MD
    • Jilian
      • Changchun, Jilian, China
        • Recruiting
        • Jilin Heart Hospital
        • Contact:
        • Principal Investigator:
          • Massimo Lemma, MD, PhD
  • Germany
      • Düsseldorf, Germany
      • Essen, Germany
        • Not yet recruiting
        • Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen
        • Contact:
          • Matthias Thielmann
        • Principal Investigator:
          • Matthias Thielmann
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen
        • Principal Investigator:
          • Martin Czerny
        • Contact:
          • Alicja Zientara
      • Giessen, Germany, 35043
      • Jena, Germany
        • Recruiting
        • Jena University Hospital
        • Contact:
          • Torsten Doenst, MD
        • Principal Investigator:
          • Torsten Doenst, MD
        • Contact:
      • München, Germany
        • Not yet recruiting
        • LMU Klinikum Campus Großhadern
        • Contact:
          • Christian Hagl
        • Principal Investigator:
          • Christian Hagl
      • Stuttgart, Germany
        • Not yet recruiting
        • Robert-Bosch-Krankenhaus Stuttgart
        • Contact:
          • Marc Albert
        • Principal Investigator:
          • Marc Albert
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Anders Jeppsson, MD, PhD
      • Gothenburg, Sweden
        • Not yet recruiting
        • Sahlgrenska University Hospital Sweden
        • Principal Investigator:
          • Bjorn Redfors, MD, PhD
        • Contact:
          • Bjorn Redfors, MD, PhD
      • Malmo, Sweden, 214 28
        • Recruiting
        • Skane University Hospital
        • Contact:
        • Principal Investigator:
          • Igor Zindovic, MD
  • United States
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Hospital
        • Contact:
        • Principal Investigator:
          • Molly Schultheis, MD
    • New York
      • Flushing, New York, United States, 11355
        • Recruiting
        • NewYork-Presbyterian: Queens Hospital
        • Contact:
        • Principal Investigator:
          • Charles A Mack, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • Mario Gaudino, MD PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor 90 mg + Low-Dose Aspirin
Drug: Ticagrelor 90 MG
Ticagrelor 90 mg twice daily taken orally for one month
Drug: Low-dose aspirin
75-150 mg once daily taken orally
Active Comparator: Low-Dose Aspirin Alone
Drug: Low-dose aspirin
75-150 mg once daily taken orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Time to all-cause mortality
  2. Time to stroke
  3. Time to myocardial infarction
  4. Time to coronary revascularization
  5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Time to all-cause mortality
  2. Time to stroke
  3. Time to myocardial infarction
  4. Time to BARC 3 bleeding
  5. Time to coronary revascularization
  6. Presence of graft failure at 12-month imaging follow-up
1 year
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:

  1. Time to all-cause mortality
  2. Time to stroke
  3. Time to myocardial infarction
  4. Time to coronary revascularization
  5. 5-year time-averaged disease-specific QOL (SAQ-7) score
5 years
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:

  1. Time to all-cause mortality
  2. Time to stroke
  3. Time to myocardial infarction
  4. Time to BARC 3 bleeding
  5. Time to coronary revascularization
  6. 5-year time-averaged disease-specific QOL (SAQ-7) score
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Marc Ruel, MD, MPH, Ottawa Heart Institute Research Corporation
  • Principal Investigator: Mario Gaudino, MD, PhD, MSCE, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-06026202
  • 2023-506613-22 (EudraCT Number)
  • 488058 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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