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NCT05997693PHASE3Recruiting

One-Month DAPT in CABG Patients

Weill Medical College of Cornell University

Start Date

8/15/2024

Completion Date

1/1/2031

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.

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, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Ticagrelor 90 MG

DRUG

Low-dose aspirin

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Conditions

Chronic Coronary Disease

Locations

Englewood Hospital

Englewood, New Jersey 07631

United States

NewYork-Presbyterian: Queens Hospital

Flushing, New York 11355

United States

Weill Cornell Medicine

New York, New York 10065

United States

Medical University Innsbruck

Innsbruck, Innsbruck 6020

Austria

Medical University Graz

Graz,

Austria

Johannes Kepler University Linz

Linz,

Austria

Medical University of Vienna

Vienna, 1090

Austria

University of Ottawa Heart Institute

Ottawa, Ontario K1Y 4W7

Canada

Ruijin Hospital: Shanghai Jiao Tong University School of Medicine

Shanghai, China 200023

China

Jilin Heart Hospital

Changchun, Jilian

China

Beijing Anzhen Hospital

Beijing, 100029

China

Center China Fuwai Hospital

Beijing,

China

University Hospital of Düsseldorf

Düsseldorf,

Germany

Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen

Essen,

Germany

Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen

Freiburg im Breisgau,

Germany

University Hospital Giessen

Giessen, 35043

Germany

Jena University Hospital

Jena,

Germany

LMU Klinikum Campus Großhadern

München,

Germany

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart,

Germany

Sahlgrenska University Hospital

Gothenburg, 413 45

Sweden

Sahlgrenska University Hospital Sweden

Gothenburg,

Sweden

Skåne University Hospital

Malmö, 214 28

Sweden