One-Month DAPT in CABG Patients

This study is looking at whether adding ticagrelor (a blood-thinning medication) for one month to low-dose aspirin is better than low-dose aspirin alone for people who have had coronary artery bypass grafting (CABG) surgery. CABG is a surgery to improve blood flow to the heart in people with chronic coronary disease. You could join if you are 18 or older and are having your first elective CABG with a saphenous vein graft. The study will measure if this treatment can reduce the risk of death, stroke, heart attack, repeat procedures, or graft failure over one year. The current recruitment status is unclear.

Study design
This is a multinational, randomized study planning to enroll 700 participants. It compares two treatment approaches for patients undergoing CABG surgery.
What's involved
You would take either ticagrelor 90 mg twice daily plus low-dose aspirin, or low-dose aspirin alone, for one month. You would also need to comply with all study procedures and follow-up for at least 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 5 years, with primary outcomes measured at 1 year.

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NCT05997693

One-Month DAPT in CABG Patients

Recruiting
PHASE3Ages 18+InterventionalPrevention
Weill Medical College of Cornell University
~700 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:Ticagrelor 90 MGLow-dose aspirin

At a glance

Recruiting sites
17 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
Measured over 1 year
Chronic Coronary Disease
22 sites across 9 states
Germany7
Austria3
China3
Sweden3
New York2
New Jersey1
Innsbruck1
Ontario1
  • Marc Ruel, MD, MPH · PRINCIPAL_INVESTIGATOR · Ottawa Heart Institute Research Corporation
  • Mario Gaudino, MD, PhD, MSCE · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

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Eligibility criteria

Inclusion

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

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.
  • 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: 1. Time to all-cause mortality 2. Time to stroke 3. Time to myocardial infarction 4. Time to coronary revascularization 5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month