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Can aspirin and strong statins shield hearts with heavy calcium buildup?

NCT ID NCT06676280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

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

40 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    32 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheonju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Dong-A University Hospital

    NOT_YET_RECRUITING

    Busan, South Korea

  • GangNeung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Gyeongsang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Haeundae paik hospital, inje university

    RECRUITING

    Busan, South Korea

  • Hallym University Chuncheon Sacred Heart Hospital

    NOT_YET_RECRUITING

    Chuncheon, South Korea

  • Hallym University Medical Center

    NOT_YET_RECRUITING

    Anyang, South Korea

  • Hanil General Hospital

    RECRUITING

    Seoul, South Korea

  • Hanyang University Seoul Hospital

    RECRUITING

    Seoul, South Korea

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

    NOT_YET_RECRUITING

    Incheon, South Korea

  • Inje University Busan Paik Hospital

    RECRUITING

    Busan, South Korea

  • Jeonbuk National University Hospital

    RECRUITING

    Jeonju, South Korea

  • Kangbuk Samsung Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kwangju Christian Hospital

    NOT_YET_RECRUITING

    Kwangju, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • SAM hospital

    NOT_YET_RECRUITING

    Anyang, South Korea

  • Sejong General Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Seoul National University Bundang hospital

    RECRUITING

    Sŏngnam, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

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

    NOT_YET_RECRUITING

    Seoul, South Korea

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

    RECRUITING

    Daejeon, South Korea

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

    RECRUITING

    Seoul, South Korea

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

    RECRUITING

    Uijeongbu-si, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Yeungnam University Medical Center

    NOT_YET_RECRUITING

    Daegu, South Korea

  • Yongin Severance Hospital

    RECRUITING

    Yongin, South Korea

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