About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 19 years or older
Patients with objectively confirmed small vessel occlusive infarctions in the subcortical or brainstem regions, identified through neuroimaging (MRI or CT)
Patients with a history of symptomatic ischemic stroke caused by the lesion described in 2), occurring within 180 days prior to enrollment
Patients or guardians who agree to the study protocol and sign with informed consent
Disqualifiers
Extracranial or intracranial large artery stenosis ≥50%
History of atherosclerotic ischemic stroke or transient ischemic attack
Documented coronary artery disease
Documented peripheral artery disease or aortic atherosclerotic disease
Trial design
Parallel
Treatments tested in this trial
Statins and/or Ezetimibe
DrugStatin ± Ezetimibe to achieve target LDL-cholesterol level
PCSK9 inhibitor
DrugThe use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Any stroke
Ischemic stroke, transient ischemic attack, or hemorrhagic stroke
Ischemic stroke or transient ischemic attack
Cardiovascular death
Myocardial infarction
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Hanmi Pharmaceutical co., ltd.
Collaborator