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)

Englewood Hospital

Englewood, New Jersey, United States

NewYork-Presbyterian: Queens Hospital

Flushing, New York, United States

Weill Cornell Medicine

New York, New York, United States

Medical University Innsbruck

Innsbruck, Innsbruck, Austria

Medical University Graz

Graz, Austria

Johannes Kepler University Linz

Linz, Austria

Medical University of Vienna

Vienna, Austria

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Ruijin Hospital: Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

Jilin Heart Hospital

Changchun, Jilian, China

Beijing Anzhen Hospital

Beijing, 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, Germany

Jena University Hospital

Jena, Germany

LMU Klinikum Campus Großhadern

München, Germany

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, Germany

Sahlgrenska University Hospital

Gothenburg, Sweden

Sahlgrenska University Hospital Sweden

Gothenburg, Sweden

Skåne University Hospital

Malmo, Sweden

View Full Details on ClinicalTrials.gov

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NCT05997693