Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07791823

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

Conditions: Intracranial Atherosclerosis ICAS

Sex: All
Ages: 19 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1626
Sponsor: Woo-Keun Seo

Location: Samsung Medical Center Seoul

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.

Eligibility Criteria

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07791823). StuddyBuddy aggregates publicly available trial information.