NCT07524335

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cardiovascular disease remains the leading cause of mortality worldwide. Recent large randomized trials have demonstrated limited net clinical benefit of aspirin in unselected primary prevention populations, leading to guideline recommendations against its systematic routine use for cardiovascular protection. Patients with subclinical coronary artery disease represent a high-risk subgroup. These individuals have documented coronary artery disease but have not experienced overt cardiovascular events or undergone revascularization. Observational data suggest that this population carries a substantially increased risk of myocardial infarction compared with individuals without coronary atherosclerosis. However, the benefit-risk balance of aspirin in this intermediate-risk group remains uncertain Primary Objective: To evaluate the recruitment rate of a pilot randomized trial comparing low-dose aspirin prescription versus no prescription. Secondary Objectives To evaluate key feasibility metrics, including: * The proportion of eligible patients who are randomized; * Adherence and persistence to the assigned intervention at 12 months; * The proportion of patients who do not complete the 12-month follow-up; * Barriers to recruitment, adherence, and retention. Exploratory Objectives: To explore clinical outcomes at 12 months, including: * The incidence of clinically significant bleeding events (BARC type 2, 3, or 5) and bleeding site; * The incidence of major adverse cardiovascular events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization; * Individual components of the composite endpoint; * Cardiovascular mortality; * Adverse Events and Serious Adverse Events.

Conditions

• Coronary Artery Disease
• Subclinical Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Prescription of Aspirin	Aspirin 81 mg orally once daily
DRUG	No prescription	No prescription of aspirin 81 mg orally once daily

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2026-04-13
• Last updated: 2026-04-15

Locations

1 site across 1 country: Canada