AzTrials
AzTrials

Chronic Coronary DiseasePhase 3ODINNCT05997693

One-Month DAPT in CABG Patients

A Phase 3 study testing Ticagrelor 90 MG and Low-dose aspirin in people with Chronic Coronary Disease, run by Weill Medical College of Cornell University at 22 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Coronary Disease
What is being tested?
Ticagrelor 90 MG and Low-dose aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
22 sitesin 6 countries
Study dates
15 Aug 2024to Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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.

Trial locations and contacts

22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Trisha Ali-Shaw contact

646-962-8281

tra2002@med.cornell.edu

22 sites in 6 countries

Germany7 sites, 7 recruiting

  • University Hospital of Düsseldorf

    Düsseldorf

    Alexander Assmann, +49-(0)211-81-18331, Alexander.Assmann@med.uni-duesseldorf.de

    Alexander Assmann

    Recruiting

  • Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen

    Essen

    Matthias Thielmann

    Matthias Thielmann

    Not yet recruiting

  • Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen

    Freiburg im Breisgau

    Alicja Zientara

    Martin Czerny

    Recruiting

  • University Hospital Giessen

    Giessen, 35043

    Andreas Böning, 0641-985-56242, andreas.boening@chiru.med.uni-giessen.de

    Andreas Böning

    Recruiting

  • Jena University Hospital

    Jena

    Torsten Doenst, MD

    49 3641 9322901, doenst@med.uni-jena.de

    Recruiting

  • LMU Klinikum Campus Großhadern

    München

    Christian Hagl

    Christian Hagl

    Not yet recruiting

  • Robert-Bosch-Krankenhaus Stuttgart

    Stuttgart

    Marc Albert

    Marc Albert

    Not yet recruiting

Other trials in Germany

Austria4 sites, 4 recruiting

  • Medical University Graz

    Graz

    Günther Laufer, 0043-316-385-82820, guenther.laufer@medunigraz.at

    Günther Laufer, MD

    Recruiting

  • Medical University Innsbruck

    Innsbruck, Innsbruck, 6020

    Elfriede Ruttmann-Ulmer, 0043 512 504 80808, Elfriede.Ruttmann@i-med.ac.at

    Elfriede Ruttmann-Ulmer

    Recruiting

  • Johannes Kepler University Linz

    Linz

    Andreas Zierer, 43 (0)57680 832136, andreas.zierer@kepleruniklinikum.at

    Andreas Zierer

    Recruiting

  • Medical University of Vienna

    Vienna, 1090

    Sigrid Sandner, MD, MSCE, 0043 1 40400 6989, sigrid.sandner@meduniwien.ac.at

    Sigrid Sandner, MD, MSCE

    Recruiting

Other trials in Austria

China4 sites, 4 recruiting

  • Beijing Anzhen Hospital

    Beijing, 100029

    Ran Dong, +86-139-1041-0620, dongran6618@hotmail.com

    Ran Dong

    Recruiting

  • Center China Fuwai Hospital

    Beijing

    Zhaoyun Cheng, +86 13903712068, chengzhy@zzu.edu.cn

    Zhaoyun Cheng

    Recruiting

  • Jilin Heart Hospital

    Changchun, Jilian

    Massimo Lemma, MD, PhD, 18644936793, dr.lemma@jlheart.org

    Massimo Lemma, MD, PhD

    Recruiting

  • Ruijin Hospital: Shanghai Jiao Tong University School of Medicine

    Shanghai, China, 200023

    Qiang Zhao, MD, zq11607@rjh.com.cn

    Qiang Zhao, MD

    Recruiting

Other trials in China

United States3 sites, 3 recruiting

  • Englewood Hospital

    Englewood, New Jersey, 07631

    Molly Schultheis, MD, 201-894-5670, Molly.Schultheis@EHMCHealth.org

    Molly Schultheis, MD

    Recruiting

  • NewYork-Presbyterian: Queens Hospital

    Flushing, New York, 11355

    Charles A Mack, MD, 718-670-2400, cmack@med.cornell.edu

    Charles A Mack, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Mario Gaudino, MD PhD, +1 212 746 1815, mfg9004@med.cornell.edu

    Mario Gaudino, MD PhD

    Recruiting

Other trials in United States

Sweden3 sites, 3 recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

    Anders Jeppsson, MD, PhD, 0046-31-3427515, anders.jeppsson@vgregion.se

    Anders Jeppsson, MD, PhD

    Recruiting

  • Sahlgrenska University Hospital Sweden

    Gothenburg

    Bjorn Redfors, MD, PhD

    Bjorn Redfors, MD, PhD

    Not yet recruiting

  • Skåne University Hospital

    Malmö, 214 28

    Igor Zindovic, MD, 0046-46-175288, igor.zindovic@med.lu.se

    Igor Zindovic, MD

    Recruiting

Other trials in Sweden

Canada1 site, 1 recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

    Marc Ruel, MD, MPH, mruel@ottawaheart.ca

    Marc Ruel, MD, MPH

    Not yet recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Ticagrelor 90 MG, Low-dose aspirin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ticagrelor 90 MGDrug

    Ticagrelor 90 mg twice daily taken orally for one month

  • Low-dose aspirinDrug

    75-150 mg once daily taken orally

Study groups in NCT05997693
Study groupRoleWhat they receive
Ticagrelor 90 mg + Low-Dose AspirinExperimentalNot described
Receives: Drug: Ticagrelor 90 MG; Drug: Low-dose aspirin
Low-Dose Aspirin AloneActive comparatorNot described
Receives: Drug: Low-dose aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 1 year

Secondary outcomes (3)

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

    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

    Measured: 1 year

  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

    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

    Measured: 5 years

  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.

    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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start15 Aug 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05997693
Sponsor's protocol ID
23-06026202
Other IDs
2023-506613-22, 488058, 2023
Acronym
ODIN
Status last verified
Dec 2025
First submitted
26 Jul 2023
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sandner S, Redfors B, Angiolillo DJ, Audisio K, Fremes SE, Janssen PWA, Kulik A, Mehran R, Peper J, Ruel M, Saw J, Soletti GJ, Starovoytov A, Ten Berg JM, Willemsen LM, Zhao Q, Zhu Y, Gaudino M. Association of Dual Antiplatelet Therapy With Ticagrelor With Vein Graft Failure After Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-analysis. JAMA. 2022 Aug 9;328(6):554-562. doi: 10.1001/jama.2022.11966.

    PubMed 35943473

  • Sandner S, Gaudino M, Redfors B, Angiolillo DJ, Ben-Yehuda O, Bhatt DL, Fremes SE, Lamy A, Marano R, Mehran R, Pocock S, Rao SV, Spertus JA, Weinsaft JW, Wells G, Ruel M. One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial. EuroIntervention. 2024 Mar 4;20(5):e322-e328. doi: 10.4244/EIJ-D-23-00699.

    PubMed 38436365

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor 90 MG and Low-dose aspirin in people with Chronic Coronary Disease, run by Weill Medical College of Cornell University at 22 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany, Austria, China, United States, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trisha Ali-Shaw (646-962-8281, tra2002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05997693, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in