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.
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
Hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or current use of antihypertensive medication)
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)
Parallel
Lipid Lowering Treatment
DrugLipid-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
Percentage change in LDL-C (from baseline)
Changes in total cholesterol, HDL-C, and triglycerides
Proportion of patients achieving target LDL-C
Changes in the degree of cerebrovascular stenosis
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Woo-Keun Seo
Lead sponsor
Samsung Medical Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
