Can stronger cholesterol drugs silence the threat of stroke?

NCT ID NCT07791823

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This trial tests whether high-intensity cholesterol-lowering therapy prevents strokes and heart problems better than moderate therapy in adults with narrowing of brain arteries but no symptoms yet. Participants are randomly assigned to one of two treatment strengths and followed over time with blood tests, imaging, and clinical checks. The goal is to see if stronger LDL cholesterol reduction lowers the risk of future vascular events like stroke or heart attack.

What this could mean

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

Active substance
Lipid-lowering therapy (cholesterol-lowering drugs, such as statins)
What this could lead to
If high-intensity therapy works better, it could prevent strokes and heart attacks in people with silent brain artery narrowing, guiding standard treatment.
What could go wrong
The trial is early and open-label, so results may be biased. High-intensity therapy may cause more side effects, and the benefit over moderate therapy is not guaranteed.

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 1,626 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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 to 80 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. Adults aged 19 to 80 years at the time of screening 2. Presence of ≥50% stenosis in at least one major intracranial artery confirmed within 12 months prior to randomization by magnetic resonance angiography (MRA), computed tomography angiography (CTA), or conventional cerebral angiography.(Target vessels include: Middle cerebral artery (M1 or M2 segment), Anterior cerebral artery (A1 or A2 segment), Posterior cerebral artery (P1 or P2 segment), Basilar artery, Vertebral artery (V4 segment)) Stenosis severity must be assessed according to the WASID (Warfarin-Aspirin Symptomatic Intracranial Disease) method 3. Baseline low-density lipoprotein cholesterol (LDL-C) level of 100-190 mg/dL, or current use of lipid-lowering therapy 4. Presence of at least one of the following vascular risk factors: * Hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or current use of antihypertensive medication) * Diabetes mellitus (fasting plasma glucose ≥126 mg/dL or ongoing antidiabetic treatment) * Current smoking * Family history of premature coronary artery disease (onset age \<55 years in men or \<65 years in women) * Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m²) Exclusion Criteria: 1. Cerebrovascular Pathologies * Prior history of symptomatic ischemic stroke or transient ischemic attack(TIA) * Previous cerebrovascular interventions, including intracranial or extracranial stenting or carotid endarterectomy * History of non-traumatic intracranial hemorrhage (ICH) * Presence of cerebral aneurysms or arteriovenous malformations (AVM) * Confirmed diagnosis of Moyamoya disease 2. Cardiovascular Comorbidities * Unstable angina pectoris or myocardial infarction (MI) within the preceding 6 months * Advanced heart failure, categorized as NYHA Class III or IV. * Severe valvular heart disease * Atrial fibrillation requiring chronic oral anticoagulation (CHA2DS2-VASc score ≥ 2, or persistent/permanent atrial fibrillation) 3. Contraindications to Lipid-Lowering Therapy * Known hypersensitivity to statins or ezetimibe * History of severe statin-associated muscle symptoms (SAMS), including rhabdomyolysis * Confirmed familial hypercholesterolemia 4. Active hepatic disease within 1 month prior to screening, or serum transaminases (ALT/AST) exceeding 3 times the upper limit of normal (ULN) 5. Type 2 diabetes mellitus requiring long-term insulin therapy, or those with established target organ damage (e.g., diabetic nephropathy, proliferative retinopathy, or clinically significant neuropathy), Type 1 diabetes mellitus with a disease duration of 20 years or more 6. Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m² 7. Women who are currently pregnant or breastfeeding 8. Patients currently enrolled in other interventional clinical trials.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Asymptomatic intracranial atherosclerotic stenosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

    1 site. 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

  • Samsung Medical Center

    Seoul, 06351, South Korea

More trials for these conditions

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