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One-Month DAPT in CABG Patients (ODIN)

Primary Purpose

Chronic Coronary Disease

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ticagrelor 90 MG
Ticagrelor placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Medicine
  • Medical University Graz
  • Medical University Innsbruck
  • Johannes Kepler University Linz
  • Medical University of Vienna
  • University of Ottawa Heart Institute
  • Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen
  • Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • Universitätsklinikum Giessen
  • LMU Klinikum Campus Großhadern
  • Robert-Bosch-Krankenhaus Stuttgart
  • Sahlgrenska University Hospital Sweden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ticagrelor 90 mg

Ticagrelor placebo

Arm Description

Outcomes

Primary Outcome Measures

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: 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

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: 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
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: 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
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: 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

Full Information

First Posted
July 26, 2023
Last Updated
August 11, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05997693
Brief Title
One-Month DAPT in CABG Patients
Acronym
ODIN
Official Title
One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor 90 mg
Arm Type
Experimental
Arm Title
Ticagrelor placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90 MG
Intervention Description
Ticagrelor 90 mg bd taken orally
Intervention Type
Drug
Intervention Name(s)
Ticagrelor placebo
Intervention Description
Ticagrelor placebo bd taken orally
Primary Outcome Measure Information:
Title
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.
Description
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
Time Frame
1 year
Title
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
Description
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
Time Frame
5 years
Title
Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.
Description
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
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trisha Ali-Shaw
Phone
646-962-8281
Email
tra2002@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Gadelrab
Email
mug4002@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ruel, MD, MPH
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Gaudino, MD, PhD, MSCE
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Gaudino, MD, PhD, MSCE
First Name & Middle Initial & Last Name & Degree
Mario Gaudino, MD, PhD, MSCE
Facility Name
Medical University Graz
City
Graz
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Just
First Name & Middle Initial & Last Name & Degree
Daniel Zimpfer
Facility Name
Medical University Innsbruck
City
Innsbruck
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elfriede Ruttmann-Ulmer
First Name & Middle Initial & Last Name & Degree
Elfriede Ruttmann-Ulmer
Facility Name
Johannes Kepler University Linz
City
Linz
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Benedikt
First Name & Middle Initial & Last Name & Degree
Andreas Zierer
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Freilinger
First Name & Middle Initial & Last Name & Degree
Sigrid Sandner, MD, MSCE
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Ruel, MD, MPH
Email
mruel@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Marc Ruel, MD, MPH
Facility Name
Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen
City
Essen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Thielmann
First Name & Middle Initial & Last Name & Degree
Matthias Thielmann
Facility Name
Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Freiburg
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicja Zientara
First Name & Middle Initial & Last Name & Degree
Martin Czerny
Facility Name
Universitätsklinikum Giessen
City
Giessen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Spänig
First Name & Middle Initial & Last Name & Degree
Andreas Böning
Facility Name
LMU Klinikum Campus Großhadern
City
München
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus Stuttgart
City
Stuttgart
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Albert
First Name & Middle Initial & Last Name & Degree
Marc Albert
Facility Name
Sahlgrenska University Hospital Sweden
City
Gothenburg
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjorn Redfors, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bjorn Redfors, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35943473
Citation
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.
Results Reference
background

Learn more about this trial

One-Month DAPT in CABG Patients

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