Your session is about to expire
← Back to Search
Antiplatelet Agent
Short-term DAPT for Coronary Artery Disease (ODIN Trial)
Phase 3
Waitlist Available
Led By Marc Ruel, MD, MPH
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Elective first-time CABG with use of ≥1 saphenous vein graft
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ODIN Trial Summary
This trial tests if a drug can help people with heart disease before and after surgery.
Who is the study for?
This trial is for adults over 18 who need their first coronary artery bypass graft using a saphenous vein and can follow the study for at least 5 years. It's not for women who could get pregnant, people with recent heart issues or surgeries, those on blood thinners or with certain health conditions like severe liver failure, cancer, or expected short lifespan.Check my eligibility
What is being tested?
The study tests if Ticagrelor (a blood-thinning medication) is more effective than a placebo in preventing complications after coronary artery bypass surgery in patients with chronic coronary disease. Participants will be randomly assigned to receive either Ticagrelor or a placebo.See study design
What are the potential side effects?
Ticagrelor may cause bleeding risks including gastrointestinal bleeding, dizziness due to reduced blood pressure, shortness of breath, and increased risk of bruising. People might also experience headaches or nausea.
ODIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am having my first CABG surgery using at least one vein from my leg.
ODIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
Secondary outcome measures
Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.
Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.
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
ODIN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ticagrelor 90 mgExperimental Treatment1 Intervention
Group II: Ticagrelor placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor 90 MG
2021
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,315,609 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
44,393 Patients Enrolled for Coronary Artery Disease
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,717 Total Patients Enrolled
26 Trials studying Coronary Artery Disease
29,478 Patients Enrolled for Coronary Artery Disease
Marc Ruel, MD, MPHPrincipal InvestigatorOttawa Heart Institute Research Corporation
3 Previous Clinical Trials
169 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
113 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of irregular heartbeat known as atrial fibrillation.I am a woman who could become pregnant.I am not allergic to ticagrelor and do not have any current severe bleeding or a history of serious brain bleeding. I am not taking strong CYP3A4 inhibitors.I need to continue taking two blood thinner medications after my heart bypass surgery.I am scheduled for surgery within the next year.I have not had any major complications like stroke or severe bleeding after surgery.I am 18 years old or older.I am having my first CABG surgery using at least one vein from my leg.I cannot take aspirin due to health reasons.You cannot have a coronary computed tomographic angiography (CCTA).I do not have severe organ failure or other serious health conditions limiting my life expectancy to under 5 years.I need medication to prevent blood clots due to a recent heart attack.I am currently using or plan to use blood thinners.I am undergoing or have undergone other heart or non-heart related surgeries.I cannot use my saphenous vein for medical procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Ticagrelor 90 mg
- Group 2: Ticagrelor placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration given its seal of approval to Ticagrelor 90 mg?
"Given its Phase 3 status, our Power team has judged the safety of Ticagrelor 90 mg to be high and rated it a 3 on a scale from 1-3. This is due to existing evidence suggesting both efficacy and multiple rounds indicating safety."
Answered by AI
How many centers in Canada are presently overseeing this clinical experiment?
"Presently, 12 distinct medical centres are participating in this trial. These locations include Graz, Innsbruck and Linz amongst other sites - it is advised that patients select the closest clinic to reduce travel costs."
Answered by AI
Is this research endeavor currently accepting participants?
"According to clinicaltrials.gov, the posting for this trial has not been updated since August 11th of 2023 and is thus no longer recruiting patients. Nonetheless, 241 other trials are open right now accepting enrollees at this moment in time."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger