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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

Must not have

Paroxysmal, persistent or permanent atrial fibrillation

Women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am having my first CABG surgery using at least one vein from my leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a type of irregular heartbeat known as atrial fibrillation.

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I am a woman who could become pregnant.

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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.

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I need to continue taking two blood thinner medications after my heart bypass surgery.

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I am scheduled for surgery within the next year.

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I have not had any major complications like stroke or severe bleeding after surgery.

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I cannot take aspirin due to health reasons.

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I do not have severe organ failure or other serious health conditions limiting my life expectancy to under 5 years.

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I am currently using or plan to use blood thinners.

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I am undergoing or have undergone other heart or non-heart related surgeries.

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I cannot use my saphenous vein for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.

Secondary study objectives

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

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,373 Previous Clinical Trials

26,518,542 Total Patients Enrolled

26 Trials studying Coronary Artery Disease

29,478 Patients Enrolled for Coronary Artery Disease

Weill Medical College of Cornell UniversityLead Sponsor

1,077 Previous Clinical Trials

1,319,967 Total Patients Enrolled

16 Trials studying Coronary Artery Disease

48,443 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

Ticagrelor (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05997693 — Phase 3

Coronary Artery Disease Research Study Groups: Ticagrelor 90 mg, Ticagrelor placebo

Coronary Artery Disease Clinical Trial 2023: Ticagrelor Highlights & Side Effects. Trial Name: NCT05997693 — Phase 3

Ticagrelor (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997693 — Phase 3

~467 spots leftby Jan 2027

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