One-Month DAPT in CABG Patients

NCT05997693 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 23-060262022023-506613-22488058
• Study Type: interventional
• Target: 700
• Locations: 6 countries
• Sites: 22

Brief 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.

Conditions

Chronic Coronary Disease

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (3)

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

  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

  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.

  5 years

Study Arms (2)

Ticagrelor 90 mg + Low-Dose Aspirin

EXPERIMENTAL

Drug: Ticagrelor 90 MG; Drug: Low-dose aspirin

Low-Dose Aspirin Alone

ACTIVE COMPARATOR

Drug: Low-dose aspirin

Interventions

Ticagrelor 90 MG DRUG

Ticagrelor 90 mg twice daily taken orally for one month

Ticagrelor 90 mg + Low-Dose Aspirin

Low-dose aspirin DRUG

75-150 mg once daily taken orally

Low-Dose Aspirin Alone; Ticagrelor 90 mg + Low-Dose Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (22)

Englewood Hospital

Englewood, New Jersey, 07631, United States

RECRUITING

NewYork-Presbyterian: Queens Hospital

Flushing, New York, 11355, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Medical University Innsbruck

Innsbruck, Innsbruck, 6020, Austria

RECRUITING

Medical University Graz

Graz, Austria

RECRUITING

Johannes Kepler University Linz

Linz, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

NOT YET RECRUITING

Ruijin Hospital: Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200023, China

RECRUITING

Jilin Heart Hospital

Changchun, Jilian, China

RECRUITING

Beijing Anzhen Hospital

Beijing, 100029, China

RECRUITING

Center China Fuwai Hospital

Beijing, China

RECRUITING

University Hospital of Düsseldorf

Düsseldorf, Germany

RECRUITING

Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen

Essen, Germany

NOT YET RECRUITING

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

Freiburg im Breisgau, Germany

RECRUITING

University Hospital Giessen

Giessen, 35043, Germany

RECRUITING

Jena University Hospital

Jena, Germany

RECRUITING

LMU Klinikum Campus Großhadern

München, Germany

NOT YET RECRUITING

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, Germany

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Sahlgrenska University Hospital Sweden

Gothenburg, Sweden

NOT YET RECRUITING

Skåne University Hospital

Malmo, 214 28, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 35943473 BACKGROUND

• 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.

  PMID: 38436365 DERIVED

MeSH Terms

Interventions

Ticagrelor; Aspirin

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marc Ruel, MD, MPH

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Mario Gaudino, MD, PhD, MSCE

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trisha Ali-Shaw

CONTACT

646-962-8281; tra2002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 18, 2023
• Study Start: August 15, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2031
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); SE (3); US (3); AU (4); CN (4); DE (7)