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

NCT ID: NCT06676280

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-24
• Study Completion Date: 2035-12-31

Brief 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).

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aspirin and High-intensity statin

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

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Patients will take aspirin 100 mg/day.

High-intensity statin

Intervention Type: DRUG

Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.

No aspirin and High-intensity statin

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

Group Type: EXPERIMENTAL

High-intensity statin

Intervention Type: DRUG

Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.

No aspirin and guideline-directed statin

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

Group Type: ACTIVE_COMPARATOR

Guideline-directed statin therapy

Intervention Type: DRUG

as 2018 Cholesterol Clinical Practice Guidelines.

Aspirin and guideline-directed statin

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

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Patients will take aspirin 100 mg/day.

Guideline-directed statin therapy

Intervention Type: DRUG

as 2018 Cholesterol Clinical Practice Guidelines.

Interventions

Aspirin

Patients will take aspirin 100 mg/day.

Intervention Type: DRUG

High-intensity statin

Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.

Intervention Type: DRUG

Guideline-directed statin therapy

as 2018 Cholesterol Clinical Practice Guidelines.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Patients who have coronary artery calcium score ≥300 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. Individuals who have symptomatic coronary artery disease or heart failure.

2. 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.

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 and flutter.

6. 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).

7. History of allergy or severe adverse reaction to aspirin or statin or ezetimibe.

8. History of myositis or myopathy with active disease in the 180 days prior to study entry.

9. Patients with active liver disease or persistent unexplained serum transaminase elevation.

10. Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.

11. History of alcohol or drug abuse.

12. Concurrent medical condition with a life expectancy of less than 1 years.

13. Pregnant and/or lactating women.

14. Patient was unable to provide written informed consent or participate in log-term follow up.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jung-min Ahn

OTHER

Sponsor Role: lead

Responsible Party

Jung-min Ahn

Professor, Cardiology, Aortic Disease Center, Cardiovascular Disease Prevention & Rehabilitation Center, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jung-min Ahn, MD

Role: CONTACT

drjmahn@gmail.com

82230104728

Facility Contacts

Jung-min Ahn, MD

Role: primary

Other Identifiers

AMCCV 2024-01

Identifier Type: -

Identifier Source: org_study_id