ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography (ASA-3C)

June 30, 2026 updated by: Jung-min Ahn

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Anyang, South Korea
        • Not yet recruiting
        • Hallym University Medical Center
        • Contact:
          • Hyun Sook Kim, MD
        • Principal Investigator:
          • Hyun Sook Kim, MD
      • Anyang, South Korea
        • Not yet recruiting
        • SAM hospital
        • Contact:
          • Il-woo Suh, MD
        • Principal Investigator:
          • Il-woo Suh, MD
      • Bucheon-si, South Korea
        • Recruiting
        • Sejong General Hospital
        • Contact:
          • Hoyun Kim, MD
        • Principal Investigator:
          • Hoyun Kim, MD
      • Busan, South Korea
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Han Young Jin, MD
        • Principal Investigator:
          • Han Young Jin, MD
      • Busan, South Korea
        • Not yet recruiting
        • Dong-A University Hospital
        • Contact:
          • Yong Rak Cho, MD
        • Principal Investigator:
          • Yong Rak Cho, MD
      • Busan, South Korea
        • Recruiting
        • Haeundae paik hospital, inje university
        • Contact:
          • Jino Park, MD
        • Principal Investigator:
          • Jino Park, MD
      • Changwon, South Korea
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
          • Jae-seok Bae, MD
        • Principal Investigator:
          • Jae-seok Bae, MD
      • Cheonju, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Principal Investigator:
          • Sang-min Kim, MD
        • Contact:
          • Sang-min Kim
      • Chuncheon, South Korea
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
          • Bong-ki Lee, MD
        • Principal Investigator:
          • Bong-ki Lee, MD
      • Chuncheon, South Korea
        • Not yet recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contact:
          • Hyun-hee Choi, MD
        • Principal Investigator:
          • Hyun-hee Choi, MD
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Cheol Hyun Lee, MD
        • Principal Investigator:
          • Cheol Hyun Lee, MD
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Namkyun Kim, MD
        • Principal Investigator:
          • Namkyun Kim, MD
      • Daegu, South Korea
        • Not yet recruiting
        • Yeungnam University Medical Center
        • Principal Investigator:
          • Ung Kim, MD
        • Contact:
          • Ung Kim, MD
      • Daejeon, South Korea
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Jae-Hyung Roh, MD
        • Principal Investigator:
          • Jae-Hyung Roh, MD
      • Daejeon, South Korea
        • Recruiting
        • The Catholic University of Korea, Daejeon St. Mary's Hosptial
        • Principal Investigator:
          • Kyusup Lee, MD
        • Contact:
          • Kyusup Lee, MD
      • Gangneung, South Korea
        • Recruiting
        • Gangneung Asan Hospital
        • Contact:
          • Hanbit Park
        • Principal Investigator:
          • Hanbit Park
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
          • Min-cheol Kim, MD
        • Principal Investigator:
          • Min-cheol Kim, MD
      • Incheon, South Korea
        • Not yet recruiting
        • Incheon St. Mary's Hospital, The Catholic University of Korea
        • Contact:
          • Ik Jun Choi, MD
        • Principal Investigator:
          • Ik Jun Choi, MD
      • Jeonju, South Korea
        • Recruiting
        • Jeonbuk National University Hospital
        • Contact:
          • Yi-Sik Kim, MD
        • Principal Investigator:
          • Yi-Sik Kim, MD
      • Kwangju, South Korea
        • Not yet recruiting
        • Kwangju Christian Hospital
        • Contact:
          • Seung-uk Lee, MD
        • Principal Investigator:
          • Seung-uk Lee, MD
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Jung-min Ahn, MD
        • Principal Investigator:
          • Jung-min Ahn, MD
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jung-Sun Kim, MD
        • Principal Investigator:
          • Jung-Sun Kim, MD
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Eun Jin Park, MD
        • Principal Investigator:
          • Eun Jin Park, MD
      • Seoul, South Korea
        • Recruiting
        • Hanyang University Seoul Hospital
        • Contact:
          • Young-Hyo Lim
        • Principal Investigator:
          • Young-Hyo Lim
      • Seoul, South Korea
        • Not yet recruiting
        • Kangbuk Samsung Hospital
        • Contact:
          • Seung-Jae Lee, MD
        • Principal Investigator:
          • Seung-Jae Lee, MD
      • Seoul, South Korea
        • Not yet recruiting
        • The Catholic University of Korea Seoul St. Mary's Hospital
        • Contact:
          • Eun Ho Chu, MD
        • Principal Investigator:
          • Eun Ho Chu, MD
      • Seoul, South Korea
        • Recruiting
        • Hanil General Hospital
        • Contact:
          • Ho-Joon Jang, MD
        • Principal Investigator:
          • Ho-Joon Jang, MD
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospitall
        • Contact:
          • Jung-Hoon Lee, MD
        • Principal Investigator:
          • Jung-Hoon Lee, MD
      • Sŏngnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Si-Hyuck Kang, MD
        • Principal Investigator:
          • Si-Hyuck Kang, MD
      • Uijeongbu-si, South Korea
        • Recruiting
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
        • Contact:
          • Seong-Min Im, MD
        • Principal Investigator:
          • Seong-Min Im, MD
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:
          • Eun-seok Shin, MD
        • Principal Investigator:
          • Eun-seok Shin, MD
      • Yongin, South Korea
        • Recruiting
        • Yongin Severance Hospital
        • Contact:
          • Yong-Cheol Kim, MD
        • Principal Investigator:
          • Yong-Cheol Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject must be aged between 40 and 75 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: No aspirin and guideline-directed statin
Patients will take no aspirin and guideline-directed statin therapy.
Drug: Guideline-directed statin therapy
Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
Experimental: Aspirin and guideline-directed statin
Patients will take aspirin 100 mg/day and guideline-directed statin therapy.
Drug: Aspirin
Patients will take aspirin 100 mg/day.
Drug: Guideline-directed statin therapy
Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
Experimental: Aspirin and High-intensity statin
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
Patients will take aspirin 100 mg/day.
Drug: High-intensity statin
Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
Experimental: No aspirin and High-intensity statin
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
Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event rate of Each individual component of primary composite outcome
Time Frame: 3 years
3 years
Event rate of Death from any causes
Time Frame: 3 years
3 years
Event rate of Hospitalization for heart failure
Time Frame: 3 years
3 years
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.
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jung-min Ahn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV 2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings