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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Aspirin 81 mg orally once daily
No prescription of aspirin 81 mg orally once daily
Montreal Heart Institute
Montreal, Quebec, Canada
RECRUITINGMonthly 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.
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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)