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).
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,
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.
Factorial
Aspirin
DrugPatients will take aspirin 100 mg/day.
High-intensity statin
DrugStatin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
Guideline-directed statin therapy
DrugStatin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
Event rate of a composite of atherosclerotic cardiovascular disease event
cardiovascular death; myocardial infarction ; hospitalization for Acute coronary syndrome; stroke; Transient ischaemic attack; peripheral arterial ischemia ;revascularization of coronary, carotid, or peripheral artery ;or death from an undetermined cause
Event rate of Each individual component of primary composite outcome
Event rate of Death from any causes
Event rate of Hospitalization for heart failure
Event rate of the first occurrence of any major bleeding
\[Safety secondary endpoint\] major bleeding is defined as a composite of intracranial hemorrhage, site-threatening bleeding event in the eye, gastrointestinal bleeding, or any other serious bleeding that resulted in hospitalization, transfusion, or that was fatal.
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Jung-min Ahn
Lead sponsor
Asan Medical Center
Sponsor institution
