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: 32

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 according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia

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 according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia

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

Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia

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 according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia

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

Eligibility Criteria

• Age: 40 Years - 75 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 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,
• 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 (32)

Hallym University Medical Center

Anyang, South Korea

NOT YET RECRUITING

SAM hospital

Anyang, South Korea

NOT YET RECRUITING

Sejong General Hospital

Bucheon-si, South Korea

RECRUITING

Dong-A University Hospital

Busan, South Korea

NOT YET RECRUITING

Haeundae paik hospital, inje university

Busan, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Chungbuk National University Hospital

Cheonju, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

NOT YET RECRUITING

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

NOT YET RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

The Catholic University of Korea, Daejeon St. Mary's Hosptial

Daejeon, South Korea

RECRUITING

GangNeung Asan Hospital

Gangneung, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Incheon St. Mary's Hospital, The Catholic University of Korea

Incheon, South Korea

NOT YET RECRUITING

Jeonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Kwangju Christian Hospital

Kwangju, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Hanil General Hospital

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

NOT YET RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

The Catholic University of Korea, Eunpyeong St. Mary's Hospitall

Seoul, South Korea

RECRUITING

Seoul National University Bundang hospital

Sŏngnam, South Korea

RECRUITING

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

Yongin Severance Hospital

Yongin, 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: July 1, 2026

Record last verified: 2026-06

Locations

KR (32)