Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorMontreal Heart Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Coronary artery calcium (CAC) score > 0;
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;
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.
Willing and able to provide informed consent and comply with study procedures
Disqualifiers
History of myocardial infarction (MI), coronary revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial revascularization procedure;
Current prescription or clear indication for aspirin, low-molecular-weight heparin (LMWH), direct oral anticoagulants, or any other antithrombotic medication;
Clear contraindication to aspirin;
History of significant bleeding within the past year;
Trial design
Design model
Parallel
Treatments tested in this trial
Prescription of Aspirin
DrugAspirin 81 mg orally once daily
No prescription
DrugNo prescription of aspirin 81 mg orally once daily
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Low-dose Aspirin PrescriptionExperimental treatment 1 intervention
Group B: No PrescriptionOther 1 intervention
Trial outcomes
Primary outcomes
1
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 initiationSecondary outcomes
1
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 initiation2
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)3
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)4
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)Other outcomes
1
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)2
Bleeding Rate (BARC 2, 3, 5)
Time frame
From enrollment to the end of follow-up (12 months)3
Adverse Event (AE) Rate and Serious Adverse Event (SAE) Rate
Time frame
From enrollment to the end of follow-up (12 months)Sponsors and contacts
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Source ClinicalTrials.gov