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Moderate Versus Intensive Lipid-lowering for Events in Asymptomatic Intracranial Stenosis

NCT07791823 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1626

Last updated 2026-08-28

No results posted yet for this study

Summary

It is designed to compare two different strengths of cholesterol-lowering treatment in patients who have narrowing of blood vessels inside the brain (intracranial atherosclerosis) but do not currently have symptoms such as stroke.

The purpose of this study is to find out whether more intensive cholesterol-lowering treatment provides better protection against future vascular events, such as stroke, compared to moderate treatment. Cholesterol, especially LDL cholesterol, is known to contribute to the buildup of plaques in blood vessels, which can lead to serious complications.

Participants in this study are adults diagnosed with asymptomatic intracranial arterial narrowing. Because they do not yet have symptoms, this study aims to prevent future problems before they occur.

This is a multicenter study, meaning it is conducted at multiple hospitals. It is prospective, so participants are followed over time. It is also randomized, which means participants are assigned by chance (like flipping a coin) into one of two groups. One group receives moderate-intensity cholesterol-lowering therapy, while the other receives high-intensity therapy. The study is open-label, meaning both doctors and patients know which treatment is being given.

Participants will undergo regular follow-up visits during the study. These visits may include blood tests, imaging studies, and clinical assessments to monitor cholesterol levels, blood vessel condition, and overall health. The researchers will track whether participants experience any vascular events, such as stroke or transient ischemic attack (TIA).

The study will also monitor safety. Any side effects or adverse reactions to the medications will be carefully recorded. This ensures that both the effectiveness and safety of the treatments are evaluated.

Conditions

  • Intracranial Atherosclerosis ICAS

Interventions

DRUG

Lipid Lowering Treatment

Lipid-lowering therapy will be administered using one or more lipid-lowering agents, as clinically appropriate. The type, dosage, and combination of lipid-lowering agents may be selected and adjusted by the treating investigator according to the participant's clinical condition, in accordance with relevant clinical practice guidelines and approved prescribing information.

Sponsors & Collaborators

  • Woo-Keun Seo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-09-30
Completion
2031-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791823 on ClinicalTrials.gov