An interventional study of Statins and/or Ezetimibe and PCSK9 inhibitor in Ischemic Stroke, Small Vessel Cerebrovascular Disease and Cholesterol, LDL, sponsored by Seoul National University Hospital. Recruiting at 46 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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 \<70 mg/dL in the absence of lipid-lowering therapy, statin contraindications, or women who are pregnant, breastfeeding, or planning pregnancy during the study period. Eligible participants will be randomized 1:1 to target LDL-cholesterol \<70 mg/dL (intensive group) or 90-110 mg/dL (standard group). The trial plans to enroll 4,016 participants, with the primary outcome being major adverse cardiovascular events-cardiovascular death, stroke, and acute coronary syndrome-during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal LDL-cholesterol target for patients with SVO stroke.
Exclusion Criteria:
Target LDL-cholesterol \<70 mg/dL
Drug: Statins and/or Ezetimibe · Drug: PCSK9 inhibitor
Target LDL-cholesterol 90-110 mg/dL
Drug: Statins and/or Ezetimibe · Drug: PCSK9 inhibitor
Statin ± Ezetimibe to achieve target LDL-cholesterol level
The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.
Major adverse cardiovascular event
Major adverse cardiovascular event (MACE) includes cardiovascular death, stroke, and acute coronoary syndrome (i.e., ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina).
Time frame: 4 years
Any stroke
Ischemic stroke, transient ischemic attack, or hemorrhagic stroke
Time frame: 4 years
Ischemic stroke or transient ischemic attack
Time frame: 4 years
Cardiovascular death
Time frame: 4 years
Myocardial infarction
Time frame: 4 years
Any death
Time frame: 4 years
Acute coronary syndrome
ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
Time frame: 4 years
Hemorrhagic stroke
Time frame: 4 years
Plan to share: No
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Seoul National University Hospital