Coronary Artery Disease, Subclinical Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Pilot Study, Feasability Study, Randomized, Clinical Trial, Prospective, Pragmatic Trial, Aspirin, Coronary artery disease, Bleeding, Major Adverse Cardiovascular Events, Antiplatelet
Brief 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.
Interventions
DRUGPrescription of Aspirin
Aspirin 81 mg orally once daily
DRUGNo prescription
No prescription of aspirin 81 mg orally once daily
Sponsors
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, randomized, controlled, parallel-group pilot study
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eligible Patients Randomized | 12 months following study enrollment initiation | 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. |
| Intervention Adherence | From randomization to the end of follow-up (12 months) | 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. |
| Intervention Persistence | From randomization to end of follow-up (12 months) | 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. |
| Proportion of Patients Lost to Follow-up | End of follow-up (12 months) | 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. |
| Barriers to Recruitment, Adherence, and Patient Retention | From recruitment to the end of follow-up (12 months) | — |
Countries
Canada
Contacts
CONTACTCyril Gagnon, MD
CONTACTSamara Bloom, MSc
Outcome results
None listed