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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506613-22 | EudraCT Number | ||
| 488058 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor 90 mg + Low-Dose Aspirin | Experimental |
| |
| Low-Dose Aspirin Alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor 90 MG | Drug | Ticagrelor 90 mg twice daily taken orally for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 year |
| 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. | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
Any indication for dual antiplatelet therapy, including
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trisha Ali-Shaw | Contact | 646-962-8281 | tra2002@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marc Ruel, MD, MPH | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Mario Gaudino, MD, PhD, MSCE | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Englewood Hospital | Recruiting | Englewood | New Jersey | 07631 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943473 | Background | 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. | |
| 38436365 |
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| Low-dose aspirin | Drug | 75-150 mg once daily taken orally |
|
| 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 | 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:
| 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. | 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:
| 5 years |
| NewYork-Presbyterian: Queens Hospital | Recruiting | Flushing | New York | 11355 | United States |
|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
|
| Medical University Innsbruck | Recruiting | Innsbruck | Innsbruck | 6020 | Austria |
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| Medical University Graz | Recruiting | Graz | Austria |
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| Johannes Kepler University Linz | Recruiting | Linz | Austria |
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| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
|
| University of Ottawa Heart Institute | Not yet recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
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| Ruijin Hospital: Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China | 200023 | China |
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| Jilin Heart Hospital | Recruiting | Changchun | Jilian | China |
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| Beijing Anzhen Hospital | Recruiting | Beijing | 100029 | China |
|
| Center China Fuwai Hospital | Recruiting | Beijing | China |
|
| University Hospital of Düsseldorf | Recruiting | Düsseldorf | Germany |
|
| Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen | Not yet recruiting | Essen | Germany |
|
| Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen | Recruiting | Freiburg im Breisgau | Germany |
|
| University Hospital Giessen | Recruiting | Giessen | 35043 | Germany |
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| Jena University Hospital | Recruiting | Jena | Germany |
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| LMU Klinikum Campus Großhadern | Not yet recruiting | München | Germany |
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| Robert-Bosch-Krankenhaus Stuttgart | Not yet recruiting | Stuttgart | Germany |
|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 413 45 | Sweden |
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| Sahlgrenska University Hospital Sweden | Not yet recruiting | Gothenburg | Sweden |
|
| Skåne University Hospital | Recruiting | Malmö | 214 28 | Sweden |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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