Aspirin in Subclinical Coronary Disease: A Pilot Randomized Trial

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 pilot randomized trial examines the feasibility of a larger phase 3 pragmatic study comparing prescribed low-dose aspirin versus no aspirin in patients with subclinical coronary artery disease. Participants have documented coronary atherosclerosis but no prior events or revascularization, making them higher risk than the general population. The trial will measure recruitment feasibility, adherence to assigned treatment, and retention at 12 months, as well as exploratory cardiovascular safety and bleeding outcomes. Primary goal is to determine if a larger trial is practical in routine clinical practice. The study is sponsored by the Montreal Heart Institute and conducted across sites in Quebec, Canada.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Documented coronary atherosclerosis, as defined by one of the following criteria:

   1. Coronary artery calcium (CAC) score \> 0;
   2. Cardiac CT angiography (CCTA) / CoroScan: lesions \<70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and \<50% in the left main coronary artery;
   3. Coronary angiography: lesions \<70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and \<50% in the left main coronary artery; if performed, physiological coronary assessments (FFR, dPR, iFR, etc.) and intracoronary imaging (IVUS or OCT) must be negative for significant disease.
2. Willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

1. History of myocardial infarction (MI), coronary revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial revascularization procedure;
2. Current prescription or clear indication for aspirin, low-molecular-weight heparin (LMWH), direct oral anticoagulants, or any other antithrombotic medication;
3. Clear contraindication to aspirin;
4. History of significant bleeding within the past year;
5. Severe illness with limited life expectancy (i.e., \<5 years);
6. Any condition that, in the investigator's judgment, would make participation unsafe for the patient.

Where it's running

• Montreal Heart Institute
  Montreal, Quebec, Canada Recruiting
• Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
  Québec, Quebec, Canada Not yet recruiting
• Centre hospitalier affilié universitaire régional (CHAUR)
  Trois-Rivières, Quebec, Canada Not yet recruiting

Study contacts

• Study coordinator: Cyril Gagnon, MD
• Email: cyril.gagnon@umontreal.ca
• Phone: 514-376-3330

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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.