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NCT06649240
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke
Conditions: Ischemic Stroke, Small Vessel Cerebrovascular Disease, Cholesterol, LDL, Secondary Prevention, Cardiovascular Diseases
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 4016
Sponsor: Seoul National University Hospital
Location: Korea University Ansan Hospital Ansan
Summary
Lipid-lowering therapy constitutes a cornerstone of secondary prevention in ischemic stroke; however, current stroke guidelines remain deficient in providing optimal target low-density lipoprotein (LDL)-cholesterol levels tailored to the stroke subtypes. Most clinical trials on LDL-cholesterol management have not differentiated between stroke subtypes or have primarily focused on large artery atherosclerosis (LAA) stroke, leaving a gap in evidence for managing LDL-cholesterol in other stroke subtypes, e.g., small vessel occlusion (SVO) stroke. While hypertension is the leading risk factor for SVO strokes, the link between elevated LDL-cholesterol and SVO stroke is also recognized. Establishing optimal LDL-cholesterol targets for SVO stroke would significantly enhance secondary prevention strategies and improve patient outcome. Thus, the investigators aim to compare intensive versus standard lipid-lowering in patients with SVO stroke. SVO70 is a multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult participants with objectively confirmed SVO stroke within 180 days of randomization will be included. Exclusion criteria include those with predefined LDL-cholesterol targets for other conditions, baseline LDL-cholesterol \
Eligibility Criteria
Inclusion Criteria:
1. Age 19 years or older
2. Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT)
3. Patients with a history of symptomatic ischemic stroke caused by the lesion described in 2), occurring within 180 days prior to enrollment
4. Patients or guardians who agree to the study protocol and sign with informed consent
Exclusion Criteria:
1. Extracranial or intracranial large artery stenosis ≥50%
2. History of atherosclerotic ischemic stroke or transient ischemic attack
3. Documented coronary artery disease
4. Documented peripheral artery disease or aortic atherosclerotic disease
5. Diabetes with one or more of the following: duration ≥10 years; ≥2 major risk factors (men ≥45 years, women ≥55 years; family history of premature atherosclerotic cardiovascular disease; hypertension; current smoking; or HDL cholesterol \
Source: ClinicalTrials.gov (NCT06649240). StuddyBuddy aggregates publicly available trial information.