An interventional study of Lipid Lowering Treatment in Intracranial Atherosclerosis ICAS, sponsored by Woo-Keun Seo. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Woo-Keun Seo · Not applicable, Interventional, and Prevention
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.
Background and Rationale Asymptomatic intracranial atherosclerotic stenosis (aICAS) is increasingly recognized as a clinically significant condition associated with an elevated risk of ischemic stroke and systemic vascular events. Despite this, there is a paucity of randomized evidence defining optimal lipid-lowering strategies in this population. Current lipid management guidelines are predominantly informed by studies in symptomatic atherosclerosis or coronary artery disease and may not be directly generalizable to patients with aICAS.
This study is designed to test the hypothesis that intensive lipid-lowering therapy targeting LDL70 mg/dL provides superior reduction in vascular events compared with a standard LDL-C target of \<100 mg/dL.
Study Design This study is a multicenter, prospective, randomized, open-label, active-controlled clinical trial.
A total of 1,626 participants will be enrolled and randomized in a 1:1 ratio to one of two treatment arms. Randomization will be performed using a centralized web-based system and stratified according to intracranial stenosis burden, baseline statin use, and the presence of diabetes mellitus.
Intervention Participants assigned to the moderate-intensity group will receive lipid-lowering therapy titrated to achieve and maintain LDL-C levels \<100 mg/dL.
Participants assigned to the intensive treatment group will receive statin-based therapy with additional lipid-lowering agents as needed to achieve and maintain LDL-C levels \<70 mg/dL.
102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.
This study's planned enrollment of 1,626 is above the median of 194 across 61 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →Woo-Keun Seo is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of at least one of the following vascular risk factors:
Exclusion Criteria:
Cerebrovascular Pathologies
Cardiovascular Comorbidities
to Lipid-Lowering Therapy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group will receive medication to maintain LDL-C levels below 70 mg/dL throughout the study period. There are no restrictions on the type of lipid-lowering agents used; all medications may be appropriately adjusted based on the participant's condition, provided they are administered within the approved dosage and administration guidelines.
Drug: Lipid Lowering Treatment
The group will receive medication to maintain LDL-C levels below 100 mg/dL throughout the study period. There are no restrictions on the type of lipid-lowering agents used; all medications may be appropriately adjusted based on the participant's condition, provided they are administered within the approved dosage and administration guidelines.
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.
Incidence of composite cardiovascular events
Cumulative incidence of composite cardiovascular events. The composite cardiovascular and cerebrovascular events are defined as follows: * Stroke (either ischemic or hemorrhagic) * Acute Coronary Syndrome (myocardial infarction or unstable angina) * Vascular Revascularization (cerebrovascular, cardiovascular, peripheral vascular, or aortic) * Cardiovascular-related death
Time frame: From enrollment until 36months
Percentage change in LDL-C (from baseline)
Time frame: From enrollment until 36months
Changes in total cholesterol, HDL-C, and triglycerides
Time frame: From enrollment until 36months
Proportion of patients achieving target LDL-C
Time frame: From enrollment until 36months
Changes in the degree of cerebrovascular stenosis
Time frame: From enrollment until 36months
Occurrence of new cerebrovascular stenosis
Time frame: From enrollment until 36months
Assessment of quality of life using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire
The EQ-5D-5L descriptive system assesses health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale from 1 to 5, with 1 indicating no problems and 5 indicating extreme problems or inability to perform the activity. Lower scores indicate better health status.
Time frame: From enrollment until 36months
Individual cardiovascular events
* Ischemic stroke * Hemorrhagic stroke * Transient Ischemic Attack (TIA) * Myocardial infarction * Coronary revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting) * All-cause mortality
Time frame: From enrollment until 36months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2031, 60 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Intracranial Arteriosclerosis →
Woo-Keun Seo