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

NCT07791823 | Not Yet Recruiting DMC

• 1 other identifier: SMC IRB 2026-06-082
• Study Type: interventional
• Target: 1,626
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AICAS

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment until 36months

Secondary Outcomes (7)

• Percentage change in LDL-C (from baseline)

  From enrollment until 36months

• Changes in total cholesterol, HDL-C, and triglycerides

  From enrollment until 36months

• Proportion of patients achieving target LDL-C

  From enrollment until 36months

• Changes in the degree of cerebrovascular stenosis

  From enrollment until 36months

• Occurrence of new cerebrovascular stenosis

  From enrollment until 36months

Study Arms (2)

High-Intensity Lipid-Lowering Therapy

EXPERIMENTAL

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

Moderate-Intensity Lipid-Lowering Therapy

ACTIVE COMPARATOR

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

Interventions

Lipid Lowering Treatment DRUG

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.

High-Intensity Lipid-Lowering Therapy; Moderate-Intensity Lipid-Lowering Therapy

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 80 years at the time of screening
• 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
• Baseline low-density lipoprotein cholesterol (LDL-C) level of 100-190 mg/dL, or current use of lipid-lowering therapy
• 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)

You may not qualify if:

• 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
• 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)
• Contraindications to Lipid-Lowering Therapy
• Known hypersensitivity to statins or ezetimibe
• History of severe statin-associated muscle symptoms (SAMS), including rhabdomyolysis
• Confirmed familial hypercholesterolemia

Sponsors & Collaborators

• Woo-Keun Seo: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Central Study Contacts

Woo-Keun Seo, Ph.D

CONTACT

82-2-3410-0799; mcastenosis@gmail.com

Seoha Kim

CONTACT

82-2-2148-7668; seoha88.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)