Status:
RECRUITING
One-Month DAPT in CABG Patients
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Chronic Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass graftin...
Detailed Description
A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repe...
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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT05997693
Start Date
August 15 2024
End Date
January 1 2031
Last Update
December 22 2025
Active Locations (22)
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1
Englewood Hospital
Englewood, New Jersey, United States, 07631
2
NewYork-Presbyterian: Queens Hospital
Flushing, New York, United States, 11355
3
Weill Cornell Medicine
New York, New York, United States, 10065
4
Medical University Innsbruck
Innsbruck, Innsbruck, Austria, 6020