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How low should cholesterol go after a small vessel stroke?

NCT ID NCT06649240

Prevention Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are comparing two LDL cholesterol targets in adults who have had a small vessel occlusion stroke, a type of stroke caused by blocked small arteries deep in the brain. Participants receive standard cholesterol-lowering drugs, with or without ezetimibe or PCSK9 inhibitors, to reach either an intensive target below 70 mg/dL or a standard target of 90 to 110 mg/dL. The trial follows about 4,000 people for at least four years to see whether the lower target reduces heart attacks, strokes, and cardiovascular deaths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Statins, ezetimibe, and PCSK9 inhibitors used to lower LDL cholesterol
What this could lead to
If intensive LDL lowering works, it could give doctors a clearer cholesterol target for preventing repeat strokes and heart problems after a small vessel stroke.
What could go wrong
The trial may find no extra benefit from pushing LDL very low, and intensive treatment can cause muscle aches, liver changes, or other side effects that make it hard to tolerate.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 4,016 people

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

Started

Oct 2024

Expected to finish

Sep 2030

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

19 years and older

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. Age 19 years or older 2. Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT) 3. Patients with a history of symptomatic ischemic stroke caused by the lesion described in 2), occurring within 180 days prior to enrollment 4. Patients or guardians who agree to the study protocol and sign with informed consent Exclusion Criteria: 1. Extracranial or intracranial large artery stenosis ≥50% 2. History of atherosclerotic ischemic stroke or transient ischemic attack 3. Documented coronary artery disease 4. Documented peripheral artery disease or aortic atherosclerotic disease 5. Diabetes with one or more of the following: duration ≥10 years; ≥2 major risk factors (men ≥45 years, women ≥55 years; family history of premature atherosclerotic cardiovascular disease; hypertension; current smoking; or HDL cholesterol \<40 mg/dL); or known evidence of target organ damage (albuminuria, estimated glomerular filtration rate \<60 mL/min per 1.73 m², retinopathy, neuropathy, or left ventricular hypertrophy) 6. Baseline LDL cholesterol \<70 mg/dL in the absence of lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors, etc.) 7. Patients contraindicated for statin use (e.g., active liver disease, serum transaminase levels elevated more than three times the normal limit, muscle disorders, hypersensitivity to statins, or taking medications contraindicated for use with statins) 8. Women who are pregnant, breastfeeding, or intending to become pregnant during the study period 9. Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Cerebral Small Vessel Diseases cerebrovascular disorder ischemic stroke prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Cholesterol, LDL Ischemic stroke Secondary prevention Small vessel cerebrovascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 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

  • Chosun University Hospital

    WITHDRAWN

    Gwangju, South Korea

  • Chung-Ang University Gwangmyeong Hospital

    RECRUITING

    Gwangmyeong, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Daegu Catholic University Medical Center

    RECRUITING

    Daegu, South Korea

  • Daejeon Eulji Medical Center

    RECRUITING

    Daejeon, South Korea

  • Dongguk University Ilsan Hospital

    WITHDRAWN

    Goyang, South Korea

  • Dongtan Sacred Heart Hospital

    RECRUITING

    Hwaseong, South Korea

  • Ewha Womans University Mokdong Hospital

    RECRUITING

    Seoul, South Korea

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Gyeongsang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Hallym University Chuncheon Sacred Heart Hospital

    RECRUITING

    Chuncheon, South Korea

  • Hallym University Kangdong Sacred Heart Hospital

    RECRUITING

    Seoul, South Korea

  • Hallym University Sacred Heart Hospital

    RECRUITING

    Anyang, South Korea

  • Hanyang University Guri Hospital

    RECRUITING

    Guri-si, South Korea

  • Hanyang University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • Ilsan Paik Hospital

    RECRUITING

    Goyang, South Korea

  • Inha University Hospital

    RECRUITING

    Incheon, South Korea

  • International St. Mary's Hospital

    WITHDRAWN

    Incheon, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Konkuk University Medical Center

    RECRUITING

    Seoul, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Ansan, South Korea

  • Kyung Hee University Medical Center

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • National Health Insurance Service Ilsan Hospital

    RECRUITING

    Goyang, South Korea

  • National Medical Center

    RECRUITING

    Seoul, South Korea

  • Nowon Eulji Medical Center

    RECRUITING

    Seoul, South Korea

  • Pusan National University Hospital

    RECRUITING

    Busan, South Korea

  • Samsung Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Wonkwang University Hospital

    RECRUITING

    Iksan, South Korea

  • Yeouido St. Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • Yongin Severance Hospital

    RECRUITING

    Yongin, South Korea

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Other studies related to the condition(s) this trial covers.