ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography (ASA-3C)

Jung-min Ahn

Status and phase: Not yet enrolling; Phase 4

Conditions: Cardiovascular Diseases

Treatments: Drug: High-intensity statin; Drug: Guideline-directed statin therapy; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT06676280

AMCCV 2024-01

Details and patient eligibility

About

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 ≥400) to prevent atherosclerotic cardiovascular disease (ASCVD) events with severe coronary calcification (CAC ≥400).

Enrollment: 5,000 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject must be aged between 40 and 70 years.

2. Patients who have coronary artery calcium score ≥400 Agatston Unit on coronary calcium computed tomography.

3. Patients who have 1 or more CVD risk factors in below;

   • dyslipidemia or,
   • diabetes or,
   • hypertension or,
   • family history of CVD or,
   • smoking

4. 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

1. Patients who are symptomatic.
2. Patients who have documented clinical ASCVD: previous myocardial infarction, acute coronary syndrome, stable angina, coronary revascularization and other arterial revascularization procedures, stroke and Transient ischaemic attack, >50% carotid stenosis or previous carotid endarterectomy or stenting, aortic aneurysm and peripheral artery disease.
3. 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).
4. 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.
5. Patients with atrial fibrillation.
6. History of allergy or severe adverse reaction to aspirin or statin
7. History of myositis or myopathy with active disease in the 180 days prior to study entry.
8. Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
9. Concurrent medical condition with a life expectancy of less than 1 years
10. Pregnant and/or lactating women
11. Patient was unable to provide written informed consent or participate in log-term follow up.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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5,000 participants in 4 patient groups

Aspirin and High-intensity statin

Experimental group

Description:

Patients will take aspirin 100 mg/day and high-intensity statin therapy. Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.

Treatment:

Drug: Aspirin

Drug: High-intensity statin

No aspirin and High-intensity statin

Experimental group

Description:

Patients will take no aspirin and high-intensity statin therapy. Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.

Treatment:

Drug: High-intensity statin

No aspirin and guideline-directed statin

Active Comparator group

Description:

Patients will take no aspirin and guideline-directed statin therapy.

Treatment:

Drug: Guideline-directed statin therapy

Aspirin and guideline-directed statin

Experimental group

Description:

Patients will take aspirin 100 mg/day and guideline-directed statin therapy.

Treatment:

Drug: Guideline-directed statin therapy

Drug: Aspirin