RecruitingPhase 4NCT06676280

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

an Investigator-initiated, Multicenter, Open-label, 2-by-2 Factorial, and Randomized Trial 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)

Sponsor

Jung-min Ahn

Enrollment

5,000 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases

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).

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether taking aspirin and/or a statin medication reduces the risk of a first heart attack or stroke in people with high coronary artery calcium scores — a sign of significant plaque buildup in the arteries. **You may be eligible if...** - You are between 40 and 70 years old - Your coronary artery calcium score is 300 or higher on a CT scan - You have one or more heart disease risk factors (high cholesterol, diabetes, high blood pressure, family history, or smoking) **You may NOT be eligible if...** - You already have symptoms of coronary artery disease or heart failure - You have had a prior heart attack, stroke, TIA, bypass surgery, or other major cardiovascular event - You already have evidence of reduced blood flow to the heart on imaging - You take aspirin or statins for an existing cardiovascular condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin

Patients will take aspirin 100 mg/day.

DRUGHigh-intensity statin

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

DRUGGuideline-directed statin therapy

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

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

Haeundae paik hospital, inje university

Busan, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Chungbuk National University Hospital

Cheonju, South Korea

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, South Korea

Kangwon National University Hospital

Chuncheon, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

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

Daejeon, South Korea

GangNeung Asan Hospital

Gangneung, South Korea

Chonnam National University Hospital

Gwangju, South Korea

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

Incheon, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Kwangju Christian Hospital

Kwangju, South Korea

Asan Medical Center

Seoul, South Korea

Hanil General Hospital

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

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

Seoul, South Korea

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

Seoul, South Korea

Seoul National University Bundang hospital

Sŏngnam, South Korea

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

Uijeongbu-si, South Korea

Ulsan University Hospital

Ulsan, South Korea

Yongin Severance Hospital

Yongin, South Korea

View Full Details on ClinicalTrials.gov

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