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

NCT06676280 | Recruiting Phase 4 DMC

• 1 other identifier: AMCCV 2024-01
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Keywords

atherosclerotic cardiovascular disease; aspirin; high-intensity statin

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (5)

• Event rate of Each individual component of primary composite outcome

  3 years

• Event rate of Death from any causes

  3 years

• Event rate of Hospitalization for heart failure

  3 years

• Event rate of the first occurrence of any major bleeding

  3 years

• Event rate of the Safety secondary endpoint

  3 years

Study Arms (4)

Aspirin and High-intensity statin

EXPERIMENTAL

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

Drug: Aspirin; Drug: High-intensity statin

No aspirin and High-intensity statin

EXPERIMENTAL

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

Drug: High-intensity statin

No aspirin and guideline-directed statin

ACTIVE COMPARATOR

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

Drug: Guideline-directed statin therapy

Aspirin and guideline-directed statin

EXPERIMENTAL

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

Drug: Aspirin; Drug: Guideline-directed statin therapy

Interventions

Guideline-directed statin therapy DRUG

as 2018 Cholesterol Clinical Practice Guidelines.

Aspirin and guideline-directed statin; No aspirin and guideline-directed statin

Aspirin DRUG

Patients will take aspirin 100 mg/day.

Aspirin and High-intensity statin; Aspirin and guideline-directed statin

High-intensity statin DRUG

Statin intensity is defined as 2018 Cholesterol Clinical Practice Guidelines.

Aspirin and High-intensity statin; No aspirin and High-intensity statin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Patients with active liver disease or persistent unexplained serum transaminase elevation.
• Patients who have significantly abnormal findings which identified violation for safety by investigator on physical examination, blood test and electrocardiogram.
• History of alcohol or drug abuse.
• Concurrent medical condition with a life expectancy of less than 1 years.
• Pregnant and/or lactating women.
• Patient was unable to provide written informed consent or participate in log-term follow up.

Sponsors & Collaborators

• Jung-min Ahn: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Jung-min Ahn, MD

CONTACT

82230104728; drjmahn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cardiology, Aortic Disease Center, Cardiovascular Disease Prevention & Rehabilitation Center, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: July 24, 2025
• Primary Completion (Estimated): March 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

KR (1)