ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorJung-min Ahn

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

5,000 Participants
are divided into 4 treatment groups

Locations

32
Hallym University Medical Center Anyang South Korea
SAM hospital Anyang South Korea
Sejong General Hospital Bucheon-si South Korea
Dong-A University Hospital Busan South Korea

Sponsors and collaborators

Jung-min Ahn

Lead sponsor

Asan Medical Center

Sponsor institution