Comparing ticagrelor plus aspirin to aspirin alone in heart surgery patients

One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients

This study tests if taking ticagrelor with aspirin for a month can help heart surgery patients do better than just taking aspirin alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Weill Medical College of Cornell University (other)
• Locations: 22 sites (Englewood, New Jersey and 21 other locations)
• Trial ID: NCT05997693 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of a one-month treatment with ticagrelor combined with low-dose aspirin compared to low-dose aspirin alone in patients with chronic coronary disease who are undergoing coronary artery bypass grafting (CABG). It is a multinational, randomized trial designed to assess the impact on critical outcomes such as death, myocardial infarction, stroke, repeat revascularization, and graft failure. Participants will be monitored for at least five years to gather comprehensive data on the long-term effects of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing their first elective CABG with the use of at least one saphenous vein graft.

Not a fit: Patients with recent acute coronary syndrome, those requiring ongoing dual antiplatelet therapy, or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing CABG.

How similar studies have performed: Previous studies have shown promising results with dual antiplatelet therapy in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Englewood, New Jersey and 21 other locations

• Englewood Hospital — Englewood, New Jersey, United States (RECRUITING)
• NewYork-Presbyterian: Queens Hospital — Flushing, New York, United States (RECRUITING)
• Weill Cornell Medicine — New York, New York, United States (RECRUITING)
• Medical University Innsbruck — Innsbruck, Innsbruck, Austria (RECRUITING)
• Medical University Graz — Graz, Austria (RECRUITING)
• Johannes Kepler University Linz — Linz, Austria (RECRUITING)
• Medical University of Vienna — Vienna, Austria (RECRUITING)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (NOT_YET_RECRUITING)
• Ruijin Hospital: Shanghai Jiao Tong University School of Medicine — Shanghai, China, China (RECRUITING)
• Jilin Heart Hospital — Changchun, Jilian, China (RECRUITING)
• Beijing Anzhen Hospital — Beijing, China (RECRUITING)
• Center China Fuwai Hospital — Beijing, China (RECRUITING)
• University Hospital of Düsseldorf — Düsseldorf, Germany (RECRUITING)
• Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen — Essen, Germany (NOT_YET_RECRUITING)
• Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen — Freiburg im Breisgau, Germany (RECRUITING)
• University Hospital Giessen — Giessen, Germany (RECRUITING)
• Jena University Hospital — Jena, Germany (RECRUITING)
• LMU Klinikum Campus Großhadern — München, Germany (NOT_YET_RECRUITING)
• Robert-Bosch-Krankenhaus Stuttgart — Stuttgart, Germany (NOT_YET_RECRUITING)
• Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
• Sahlgrenska University Hospital Sweden — Gothenburg, Sweden (NOT_YET_RECRUITING)
• Skåne University Hospital — Malmö, Sweden (RECRUITING)

Study contacts

• Principal investigator: Marc Ruel, MD, MPH — Ottawa Heart Institute Research Corporation
• Study coordinator: Trisha Ali-Shaw

Conditions: Chronic Coronary Disease