RecruitingPhase 3NCT05997693
One-Month DAPT in CABG Patients
One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
Sponsor
Weill Medical College of Cornell University
Enrollment
700 participants
Start Date
Aug 15, 2024
Study Type
INTERVENTIONAL
Conditions
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 grafting.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria19
- 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.
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Interventions
DRUGTicagrelor 90 MG
Ticagrelor 90 mg twice daily taken orally for one month
DRUGLow-dose aspirin
75-150 mg once daily taken orally
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05997693