A Phase 3 interventional study of Prescription of Aspirin and No prescription in Coronary Artery Disease and Subclinical Atherosclerotic Cardiovascular Disease, sponsored by Montreal Heart Institute. Recruiting at 3 sites in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Montreal Heart Institute · Phase 3, Interventional, and Prevention
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.
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:
Exploratory Objectives:
To explore clinical outcomes at 12 months, including:
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 48 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented coronary atherosclerosis, as defined by one of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aspirin 81 mg orally once daily prescription
Drug: Prescription of Aspirin
No prescription of aspirin 81 mg orally once daily
Drug: No prescription
Aspirin 81 mg orally once daily
No prescription of aspirin 81 mg orally once daily
Monthly Recruitment Rate
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.
Time frame: 12 months following study enrollment initiation
Proportion of Eligible Patients Randomized
Proportion of eligible patients who are randomized: 0% ≤ Proportion \< 30% = study not feasible, major protocol modifications required; 30% ≤ Proportion \< 61% = study feasible with protocol modifications; ≥ 61% = study feasible without protocol modifications.
Time frame: 12 months following study enrollment initiation
Intervention Adherence
Proportion of days on which patients take the assigned intervention (adherence): 0% ≤ Mean proportion \< 25% = study not feasible, major protocol modifications required; 25% ≤ Mean proportion \< 74% = study feasible with protocol modifications; ≥ 74% = study feasible without protocol modifications.
Time frame: From randomization to the end of follow-up (12 months)
Intervention Persistence
Proportion of patients who still take the assigned intervention at 12 months of follow-up (persistence): 0% ≤ Proportion \< 25% = study not feasible, major protocol modifications required; 25% ≤ Proportion \< 70% = study feasible with protocol modifications; ≥ 70% = study feasible without protocol modifications.
Time frame: From randomization to end of follow-up (12 months)
Proportion of Patients Lost to Follow-up
Proportion of patients who do not complete the 12-month follow-up visit: ≥ 10% = study not feasible, major protocol modifications required; 6% ≤ Proportion \< 10% = study feasible with protocol modifications; 0% ≤ Proportion \< 6% = study feasible without protocol modifications.
Time frame: End of follow-up (12 months)
Barriers to Recruitment, Adherence, and Patient Retention
Time frame: From recruitment to the end of follow-up (12 months)
Major Adverse Cardiovascular Event (MACE) Rate
MACE rate (all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization) at 12 months of follow-up
Time frame: From enrollment to the end of follow-up (12 months)
Bleeding Rate (BARC 2, 3, 5)
Time frame: From enrollment to the end of follow-up (12 months)
Adverse Event (AE) Rate and Serious Adverse Event (SAE) Rate
Time frame: From enrollment to the end of follow-up (12 months)
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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