Ireland
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Recruiting Phase 3

Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial

NCT07524335 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2026-07-21
Last updated
2026-09-23

Condition(s) studied

Coronary Artery DiseaseSubclinical Atherosclerotic Cardiovascular Disease

Investigational drug(s) / intervention(s)

Prescription of AspirinNo prescription

Prescription of Aspirin: Aspirin 81 mg orally once daily

No prescription: No prescription of aspirin 81 mg orally once daily

Study summary

In patients with subclinical coronary artery disease, the ASCAD-P study aims to assess the feasibility of a larger phase 3 pragmatic randomized controlled trial comparing prescription versus no prescription of low-dose aspirin in routine clinical practice.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Monthly Recruitment Rate — 12 months following study enrollment initiation
    Average monthly patient recruitment rate: 0 ≤ Mean rate (patients/month) \< 2 = study not feasible; 2 ≤ Mean rate (patients/month) \< 4 = study feasible with protocol modifications; ≥ 4 Mean rate (patients/month) = study feasible without major protocol modifications.

Trial sites (1)

FacilityCityRegionStatus
Montreal Heart Institute Montreal Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07524335 on ClinicalTrials.gov ↗ ← All trials in Canada