Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2024-08-15
2031-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Low-Dose Aspirin Alone
Low-dose aspirin
75-150 mg once daily taken orally
Ticagrelor 90 mg + Low-Dose Aspirin
Ticagrelor 90 MG
Ticagrelor 90 mg twice daily taken orally for one month
Low-dose aspirin
75-150 mg once daily taken orally
Interventions
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Ticagrelor 90 MG
Ticagrelor 90 mg twice daily taken orally for one month
Low-dose aspirin
75-150 mg once daily taken orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Marc Ruel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Mario Gaudino, MD, PhD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Englewood Hospital
Englewood, New Jersey, United States
NewYork-Presbyterian: Queens Hospital
Flushing, New York, United States
Weill Cornell Medicine
New York, New York, United States
Medical University Innsbruck
Innsbruck, Innsbruck, Austria
Medical University Graz
Graz, , Austria
Johannes Kepler University Linz
Linz, , Austria
Medical University of Vienna
Vienna, , Austria
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Ruijin Hospital: Shanghai Jiao Tong University School of Medicine
Shanghai, China, China
Jilin Heart Hospital
Changchun, Jilian, China
Beijing Anzhen Hospital
Beijing, , China
Center China Fuwai Hospital
Beijing, , China
University Hospital of Düsseldorf
Düsseldorf, , Germany
Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen
Essen, , Germany
Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, , Germany
University Hospital Giessen
Giessen, , Germany
Jena University Hospital
Jena, , Germany
LMU Klinikum Campus Großhadern
München, , Germany
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart, , Germany
Sahlgrenska University Hospital
Gothenburg, , Sweden
Sahlgrenska University Hospital Sweden
Gothenburg, , Sweden
Skåne University Hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Molly Schultheis, MD
Role: primary
Charles A Mack, MD
Role: primary
Mario Gaudino, MD PhD
Role: primary
Elfriede Ruttmann-Ulmer
Role: primary
Günther Laufer
Role: primary
Andreas Zierer
Role: primary
Sigrid Sandner, MD, MSCE
Role: primary
Marc Ruel, MD, MPH
Role: primary
Qiang Zhao, MD
Role: primary
Massimo Lemma, MD, PhD
Role: primary
Ran Dong
Role: primary
Zhaoyun Cheng
Role: primary
Alexander Assmann
Role: primary
Matthias Thielmann
Role: primary
Alicja Zientara
Role: primary
Andreas Böning
Role: primary
Torsten Doenst, MD
Role: primary
Role: backup
Christian Hagl
Role: primary
Marc Albert
Role: primary
Anders Jeppsson, MD, PhD
Role: primary
Bjorn Redfors, MD, PhD
Role: primary
Igor Zindovic, MD
Role: primary
References
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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.
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.
Other Identifiers
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2023-506613-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
488058
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23-06026202
Identifier Type: -
Identifier Source: org_study_id