Cardiovascular DiseasesPhase 4ASA-3CNCT06676280
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
A Phase 4 study testing Aspirin, High-intensity statin and Guideline-directed statin therapy in people with Cardiovascular Diseases, run by Jung-min Ahn at 32 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Aspirin, High-intensity statin and Guideline-directed statin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 32 sitesSouth Korea
- Study dates
- 24 Jul 2025to 31 Dec 2035
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
South Korea32 sites, 32 recruiting
- Not yet recruiting
Hallym University Medical Center
Anyang
Hyun Sook Kim, MD
Hyun Sook Kim, MD
- Not yet recruiting
SAM hospital
Anyang
Il-woo Suh, MD
Il-woo Suh, MD
- Recruiting
Sejong General Hospital
Bucheon-si
Hoyun Kim, MD
Hoyun Kim, MD
- Not yet recruiting
Dong-A University Hospital
Busan
Yong Rak Cho, MD
Yong Rak Cho, MD
- Recruiting
Haeundae paik hospital, inje university
Busan
Jino Park, MD
Jino Park, MD
- Recruiting
Inje University Busan Paik Hospital
Busan
Han Young Jin, MD
Han Young Jin, MD
- Recruiting
Gyeongsang National University Changwon Hospital
Changwon
Jae-seok Bae, MD
Jae-seok Bae, MD
- Recruiting
Chungbuk National University Hospital
Cheonju
Sang-min Kim
Sang-min Kim, MD
- Not yet recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon
Hyun-hee Choi, MD
Hyun-hee Choi, MD
- Recruiting
Kangwon National University Hospital
Chuncheon
Bong-ki Lee, MD
Bong-ki Lee, MD
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Cheol Hyun Lee, MD
Cheol Hyun Lee, MD
- Recruiting
Kyungpook National University Hospital
Daegu
Namkyun Kim, MD
Namkyun Kim, MD
- Not yet recruiting
Yeungnam University Medical Center
Daegu
Ung Kim, MD
Ung Kim, MD
- Recruiting
Chungnam National University Hospital
Daejeon
Jae-Hyung Roh, MD
Jae-Hyung Roh, MD
- Recruiting
The Catholic University of Korea, Daejeon St. Mary's Hosptial
Daejeon
Kyusup Lee, MD
Kyusup Lee, MD
- Recruiting
GangNeung Asan Hospital
Gangneung
Hanbit Park
Hanbit Park
- Recruiting
Chonnam National University Hospital
Gwangju
Min-cheol Kim, MD
Min-cheol Kim, MD
- Not yet recruiting
Incheon St. Mary's Hospital, The Catholic University of Korea
Incheon
Ik Jun Choi, MD
Ik Jun Choi, MD
- Recruiting
Jeonbuk National University Hospital
Jeonju
Yi-Sik Kim, MD
Yi-Sik Kim, MD
- Not yet recruiting
Kwangju Christian Hospital
Kwangju
Seung-uk Lee, MD
Seung-uk Lee, MD
- Recruiting
Asan Medical Center
Seoul
Jung-min Ahn, MD
Jung-min Ahn, MD
- Recruiting
Hanil General Hospital
Seoul
Ho-Joon Jang, MD
Ho-Joon Jang, MD
- Recruiting
Hanyang University Seoul Hospital
Seoul
Young-Hyo Lim
Young-Hyo Lim
- Not yet recruiting
Kangbuk Samsung Hospital
Seoul
Seung-jae Lee, MD
Seung-jae Lee, MD
- Recruiting
Korea University Guro Hospital
Seoul
Eun Jin Park, MD
Eun Jin Park, MD
- Recruiting
Severance Hospital
Seoul
Jung-Sun Kim, MD
Jung-Sun Kim, MD
- Not yet recruiting
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Eun Ho Chu, MD
Eun Ho Chu, MD
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospitall
Seoul
Jung-Hoon Lee, MD
Jung-Hoon Lee, MD
- Recruiting
Seoul National University Bundang hospital
Sŏngnam
Si-Hyuck Kang, MD
Si-Hyuck Kang, MD
- Recruiting
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si
Seong-Min Im, MD
Seong-Min Im, MD
- Recruiting
Ulsan University Hospital
Ulsan
Eun-Seok Shin, MD
Eun-Seok Shin, MD
- Recruiting
Yongin Severance Hospital
Yŏngin
Yong-Cheol Kim, MD
Yong-Cheol Kim, MD
About this study
Official 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)
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
- Being tested
- Aspirin, High-intensity statin, Guideline-directed statin therapy
- Keywords
- atherosclerotic cardiovascular disease, aspirin, high-intensity statin
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Patients will take aspirin 100 mg/day.
High-intensity statinDrug
Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
Guideline-directed statin therapyDrug
Statin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: High-intensity statin |
| No aspirin and guideline-directed statin | Active comparator | Patients will take no aspirin and guideline-directed statin therapy. Receives: Drug: Guideline-directed statin therapy |
| Aspirin and guideline-directed statin | Experimental | Patients will take aspirin 100 mg/day and guideline-directed statin therapy. Receives: Drug: Aspirin; Drug: Guideline-directed statin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (5)
Event rate of Each individual component of primary composite outcome
Measured: 3 years
Event rate of Death from any causes
Measured: 3 years
Event rate of Hospitalization for heart failure
Measured: 3 years
Event rate of the first occurrence of any major bleeding
[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.
Measured: 3 years
Event rate of the Safety secondary endpoint
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start24 Jul 2025
- Primary completion31 Mar 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jung-min Ahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jung-min Ahn, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676280
- Sponsor's protocol ID
- AMCCV 2024-01
- Acronym
- ASA-3C
- Status last verified
- Jun 2026
- First submitted
- 4 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06676280
- Acronym / sponsor ID
- ASA-3C / AMCCV 2024-01
- Conditions
- Cardiovascular Diseases
- Keywords
- atherosclerotic cardiovascular disease, aspirin, high-intensity statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Jung-min AhnUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 31 Mar 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aspirin and High-intensity statin | Experimental | Drug: Aspirin, Drug: High-intensity statinPatients 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 |
| No aspirin and High-intensity statin | Experimental | Drug: High-intensity statinPatients 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 |
| No aspirin and guideline-directed statin | Active comparator | Drug: Guideline-directed statin therapyPatients will take no aspirin and guideline-directed statin therapy. |
| Aspirin and guideline-directed statin | Experimental | Drug: Aspirin, Drug: Guideline-directed statin therapyPatients will take aspirin 100 mg/day and guideline-directed statin therapy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinPatients will take aspirin 100 mg/day. | Drug | Aspirin and High-intensity statin, Aspirin and guideline-directed statin |
| High-intensity statinStatin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia | Drug | Aspirin and High-intensity statin, No aspirin and High-intensity statin |
| Guideline-directed statin therapyStatin intensity is defined according to the 2026 ACC/AHA Guideline on the Management of Dyslipidemia | Drug | Aspirin and guideline-directed statin, No aspirin and guideline-directed statin |
Primary outcome
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
5 secondary outcomes
Event rate of Each individual component of primary composite outcome
Time frame: 3 years
Event rate of Death from any causes
Time frame: 3 years
Event rate of Hospitalization for heart failure
Time frame: 3 years
Event rate of the first occurrence of any major bleeding
Time frame: 3 years
Event rate of the Safety secondary endpoint
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin, High-intensity statin and Guideline-directed statin therapy in people with Cardiovascular Diseases, run by Jung-min Ahn at 32 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-min Ahn, MD (82230104728, drjmahn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event rate of a composite of atherosclerotic cardiovascular disease event (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.