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One-Month DAPT in CABG Patients
RECRUITINGPhase 3Sponsored by Weill Medical College of Cornell University
Actively Recruiting
PhasePhase 3
SponsorWeill Medical College of Cornell University
Started2024-08-15
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT05997693
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
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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.
Conditions2
Chronic Coronary DiseaseHeart Disease
Locations3 sites
New Jersey
1 siteEnglewood Hospital
Englewood, New Jersey, 07631
New York
2 sitesNewYork-Presbyterian: Queens Hospital
Flushing, New York, 11355
Weill Cornell Medicine
New York, New York, 10065
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 3
SponsorWeill Medical College of Cornell University
Started2024-08-15
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT05997693