Can aspirin and strong statins shield hearts with heavy calcium buildup?
NCT ID NCT06676280
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study is testing whether taking daily aspirin (100 mg) along with a high-intensity statin can prevent heart attacks, strokes, and other serious cardiovascular events in people aged 40–75 who have severe coronary artery calcification (calcium score ≥300). About 5,000 participants will be randomly assigned to different combinations of aspirin and statin therapy. The goal is to find the best way to reduce risk in this high-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin and high-intensity statin therapy
- What this could lead to
- If successful, this could show that a combination of daily aspirin and a strong statin significantly reduces the risk of heart attacks, strokes, and other cardiovascular events in people with severe coronary calcification.
- What could go wrong
- This is a Phase 4 trial, but results may not apply to everyone. Aspirin increases bleeding risk, and high-intensity statins can cause muscle pain or liver issues. The study is large but still may not prove benefit for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 5,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
32 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
RECRUITINGSeoul, South Korea
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Chonnam National University Hospital
RECRUITINGGwangju, South Korea
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Chungbuk National University Hospital
RECRUITINGCheonju, South Korea
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Chungnam National University Hospital
RECRUITINGDaejeon, South Korea
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Dong-A University Hospital
NOT_YET_RECRUITINGBusan, South Korea
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GangNeung Asan Hospital
RECRUITINGGangneung, South Korea
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Gyeongsang National University Changwon Hospital
RECRUITINGChangwon, South Korea
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Haeundae paik hospital, inje university
RECRUITINGBusan, South Korea
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Hallym University Chuncheon Sacred Heart Hospital
NOT_YET_RECRUITINGChuncheon, South Korea
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Hallym University Medical Center
NOT_YET_RECRUITINGAnyang, South Korea
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Hanil General Hospital
RECRUITINGSeoul, South Korea
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Hanyang University Seoul Hospital
RECRUITINGSeoul, South Korea
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Incheon St. Mary's Hospital, The Catholic University of Korea
NOT_YET_RECRUITINGIncheon, South Korea
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Inje University Busan Paik Hospital
RECRUITINGBusan, South Korea
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Jeonbuk National University Hospital
RECRUITINGJeonju, South Korea
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Kangbuk Samsung Hospital
NOT_YET_RECRUITINGSeoul, South Korea
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Kangwon National University Hospital
RECRUITINGChuncheon, South Korea
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Keimyung University Dongsan Medical Center
RECRUITINGDaegu, South Korea
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Korea University Guro Hospital
RECRUITINGSeoul, South Korea
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Kwangju Christian Hospital
NOT_YET_RECRUITINGKwangju, South Korea
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Kyungpook National University Hospital
RECRUITINGDaegu, South Korea
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SAM hospital
NOT_YET_RECRUITINGAnyang, South Korea
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Sejong General Hospital
RECRUITINGBucheon-si, South Korea
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Seoul National University Bundang hospital
RECRUITINGSŏngnam, South Korea
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Severance Hospital
RECRUITINGSeoul, South Korea
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The Catholic University of Korea Seoul St. Mary's Hospital
NOT_YET_RECRUITINGSeoul, South Korea
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The Catholic University of Korea, Daejeon St. Mary's Hosptial
RECRUITINGDaejeon, South Korea
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The Catholic University of Korea, Eunpyeong St. Mary's Hospitall
RECRUITINGSeoul, South Korea
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The Catholic University of Korea, Uijeongbu St. Mary's Hospital
RECRUITINGUijeongbu-si, South Korea
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Ulsan University Hospital
RECRUITINGUlsan, South Korea
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Yeungnam University Medical Center
NOT_YET_RECRUITINGDaegu, South Korea
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Yongin Severance Hospital
RECRUITINGYongin, South Korea
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