About this trial
The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥300) to prevent atherosclerotic cardiovascular disease (ASCVD) events with severe coronary calcification (CAC ≥300).
Eligibility criteria
Qualifiers
The subject must be aged between 40 and 75 years.
Patients who have coronary artery calcium score ≥300 Agatston Unit on coronary calcium computed tomography.
Patients who have 1 or more CVD risk factors in below;
dyslipidemia or,
Disqualifiers
Individuals who have symptomatic coronary artery disease or heart failure.
Patients who have documented clinical Atherosclerotic Cardiovascular Disease: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization procedures, stroke and Transient ischaemic attack (TIA), >50% carotid stenosis or previous carotid endarterectomy or stenting, aortic aneurysm and peripheral artery disease.
Patients who have evidence of myocardial ischemia on non-invasive stress test including stress single photon emission CT myocardial perfusion imaging (SPECT MPI), cardiovascular magnetic resonance (CMR) imaging, stress echocardiography, or treadmill test, or on invasive stress test including Fractional flow reserve (FFR) < 0.80 on invasive coronary angiography (diameter stenosis>50% without objective evidence of ischemia could be enrolled).
Patients at high risk of bleeding: gastrointestinal hemorrhage or peptic ulcer within the previous 6 months; active hepatic disease such as cirrhosis or active hepatitis; use of warfarin, or other anticoagulant therapy; or has a history of aspirin allergy.
Trial design
Treatments tested in this trial
- Aspirin
- High-intensity statin
- Guideline-directed statin therapy
Treatment groups
Locations
32Sponsors and collaborators
Jung-min Ahn
Lead sponsor
Asan Medical Center
Sponsor institution