Comparing ticagrelor plus aspirin to aspirin alone in heart surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Marc Ruel, MD, MPH — Ottawa Heart Institute Research Corporation
• Study coordinator: Trisha Ali-Shaw
• Email: tra2002@med.cornell.edu
• Phone: 646-962-8281

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.