Recruiting
Phase 3

Ticagrelor & Aspirin

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05997693

Conditions

Chronic Coronary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ticagrelor 90 MG

Low-dose aspirin

Study Details

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 grafting.

Conditions

Chronic Coronary Disease

Study ID

NCT05997693

Start date

Aug 15, 2024

Status verified date

Dec, 2025

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ticagrelor 90 mg + Low-Dose Aspirin

active comparator: Low-Dose Aspirin Alone

Interventions

Ticagrelor 90 MG

Ticagrelor 90 mg twice daily taken orally for one month

Low-dose aspirin

75-150 mg once daily taken orally

Primary outcome measure

  • Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Trisha Ali-Shaw

646-962-8281tra2002@med.cornell.edu

Locations

Englewood Hospital

Recruiting

Englewood, New Jersey, United States, 07631

Contacts

Molly Schultheis, MD

201-894-5670Molly.Schultheis@EHMCHealth.org

Principal Investigator:

Molly Schultheis, MD

NewYork-Presbyterian: Queens Hospital

Recruiting

Flushing, New York, United States, 11355

Contacts

Charles A Mack, MD

718-670-2400cmack@med.cornell.edu

Principal Investigator:

Charles A Mack, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Mario Gaudino, MD PhD

+1 212 746 1815mfg9004@med.cornell.edu

Principal Investigator:

Mario Gaudino, MD PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-12-22.