ODIN: One-Month DAPT in CABG Patients

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05997693
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 700
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 84
• Patients Per Site: 58.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Condition or Disease	Intervention/Treatment	Phase
Chronic Coronary Disease	Drug: Ticagrelor 90 MG; Drug: Ticagrelor placebo	Phase 3

Detailed Description

A multinational, randomized, double-blind, placebo-controlled trial to evaluate the effect of one-month ticagrelor twice daily in addition to low-dose aspirin 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor 90 mg	Drug: Ticagrelor 90 MG; Ticagrelor 90 mg bd taken orally
Placebo Comparator: Ticagrelor placebo	Drug: Ticagrelor placebo; Ticagrelor placebo bd taken orally

Outcome Measures

Primary Outcome Measures

1. Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. [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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to coronary revascularization Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month

Secondary Outcome Measures

1. 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]

   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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to BARC 3 bleeding Time to coronary revascularization Presence of graft failure at 12-month imaging follow-up

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 [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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to coronary revascularization 5-year time-averaged disease-specific QOL (SAQ-7) score

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. [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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to BARC 3 bleeding Time to coronary revascularization 5-year time-averaged disease-specific QOL (SAQ-7) score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065
2	Medical University Graz	Graz		Austria
3	Medical University Innsbruck	Innsbruck		Austria
4	Johannes Kepler University Linz	Linz		Austria
5	Medical University of Vienna	Vienna		Austria	1090
6	University of Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
7	Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen	Essen		Germany
8	Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen	Freiburg		Germany
9	Universitätsklinikum Giessen	Giessen		Germany
10	LMU Klinikum Campus Großhadern	München		Germany
11	Robert-Bosch-Krankenhaus Stuttgart	Stuttgart		Germany
12	Sahlgrenska University Hospital Sweden	Gothenburg		Sweden

Sponsors and Collaborators

• Weill Medical College of Cornell University
• 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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT05997693
• Other Study ID Numbers: 23-06026202; 2023-506613-22; 488058
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Coronary Disease; Ticagrelor

Study Results

No Results Posted as of Aug 18, 2023