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NCT Number: NCT06676280

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

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).

Recruiting

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hallym University Medical Center, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Aspirin

Drug

Patients will take aspirin 100 mg/day.

High-intensity statin

Drug

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

Guideline-directed statin therapy

Drug

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

Primary outcomes

  1. Event rate of a composite of atherosclerotic cardiovascular disease event

    Time frame: 3 years

    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

Secondary outcomes

  1. Event rate of Each individual component of primary composite outcome

    Time frame: 3 years

  2. Event rate of Death from any causes

    Time frame: 3 years

  3. Event rate of Hospitalization for heart failure

    Time frame: 3 years

  4. Event rate of the first occurrence of any major bleeding

    Time frame: 3 years

    [Safety secondary endpoint] major bleeding is defined as a composite of intracranial hemorrhage, site-threatening bleeding event in the eye, gastrointestinal bleeding, or any other serious bleeding that resulted in hospitalization, transfusion, or that was fatal.

  5. Event rate of the Safety secondary endpoint

    Time frame: 3 years

    Safety secondary endpoint:

    Aspirin the first occurrence of any major bleeding; a composite of intracranial hemorrhage, site-threatening bleeding event in the eye, gastrointestinal bleeding, or any other serious bleeding that resulted in hospitalization, transfusion, or that was fatal.

    Statin

    • Muscle related adverse events; myalgia, myositis, myopathy, myonecrosis, rhabdomyolysis
    • New onset diabetes mellitus
    • Gall bladder-related adverse events
    • Cancer diagnosis
    • Cataract operation
    • New-onset neurocognitive disorder
    • Discontinuation or dose-reduction of statin therapy by intolerance

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-min Ahn, MD

CONTACT

[email protected]

82230104728

Sponsors and collaborators

Lead sponsor

Jung-min Ahn

Other

Registry information

Official study title

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)

Acronym: ASA-3C

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Nov 6, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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