Determining the best LDL cholesterol levels for small vessel occlusion stroke prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish optimal low-density lipoprotein (LDL) cholesterol targets specifically for patients who have experienced small vessel occlusion (SVO) strokes. It will compare the effects of intensive versus standard lipid-lowering therapies, including statins and other medications, on secondary prevention of ischemic strokes. By focusing on a specific subtype of stroke, the study seeks to fill a gap in current guidelines and improve patient outcomes through tailored cholesterol management. Participants will be recruited from multiple centers and will undergo rigorous screening to ensure eligibility based on defined criteria.

Why it matters

Who can join: the full rules

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 \<40 mg/dL); or known evidence of target organ damage (albuminuria, estimated glomerular filtration rate \<60 mL/min per 1.73 m², retinopathy, neuropathy, or left ventricular hypertrophy)
6. Baseline LDL cholesterol \<70 mg/dL in the absence of lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors, etc.)
7. Patients contraindicated for statin use (e.g., active liver disease, serum transaminase levels elevated more than three times the normal limit, muscle disorders, hypersensitivity to statins, or taking medications contraindicated for use with statins)
8. Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
9. Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion

Where it's running

• Korea University Ansan Hospital
  Ansan, South Korea Recruiting
• Hallym University Sacred Heart Hospital
  Anyang, South Korea Recruiting
• Pusan National University Hospital
  Busan, South Korea Recruiting
• Gyeongsang National University Changwon Hospital
  Changwon, South Korea Recruiting
• Samsung Changwon Hospital
  Changwon, South Korea Recruiting
• Chungbuk National University Hospital
  Cheongju-si, South Korea Recruiting

Study contacts

• Principal investigator: Seung-Hoon Lee, MD, PhD — Seoul National University Hospital
• Study coordinator: Wookjin Yang, MD, PhD
• Email: ywj_2002@naver.com
• Phone: +82-70-4352-2482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.