ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Comput… (NCT06676280) | Clinical Trial Compass
RecruitingPhase 4
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
South Korea5,000 participantsStarted 2025-07-24
Plain-language summary
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).
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion criteria
✓. The subject must be aged between 40 and 70 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;
✓. Patients agree to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
✕. 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.
What they're measuring
1
Event rate of a composite of atherosclerotic cardiovascular disease event
✕. Patients with atrial fibrillation and flutter.
✕. Patients with severe left ventricular dysfunction (ejection fraction ≤30%) or severe valvular heart disease who experience dyspnea on exertion (The NYHA (New York Heart Association) Functional Classification III-IV).
✕. History of allergy or severe adverse reaction to aspirin or statin or ezetimibe.
✕. History of myositis or myopathy with active disease in the 180 days prior to study entry.