Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Prescription of Aspirin
- No prescription
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov