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NCT06649240Recruiting

Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke

Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke (SVO70)

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
4016 (estimated)
First submitted
14 Oct 2024
Start date
4 Oct 2024
Primary completion date
30 Sept 2030
Lead sponsor
Seoul National University Hospital
Diseases
Stroke
NCT number
NCT06649240

What you commit to

  • Study type: Interventional
  • Planned participants: 4016
  • From 4 Oct 2024 to the primary completion date, 30 Sept 2030
  • 46 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of atherosclerotic ischemic stroke or transient ischemic attack
  • Documented coronary artery disease
  • Documented peripheral artery disease or aortic atherosclerotic disease

Lab values

  • 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)
  • Baseline LDL cholesterol \<70 mg/dL in the absence of lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors, etc.)
  • 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)

Other

  • Extracranial or intracranial large artery stenosis ≥50%
  • Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
  • Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Korea University Ansan Hospital
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AnsanSouth KoreaRecruiting
Hallym University Sacred Heart Hospital
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AnyangSouth KoreaRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Gyeongsang National University Changwon hospital
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ChangwonSouth KoreaRecruiting
Samsung Changwon Hospital
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ChangwonSouth KoreaRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Hallym University Chuncheon Sacred Heart Hospital
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ChuncheonSouth KoreaRecruiting
Kangwon National University Hospital
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ChuncheonSouth KoreaRecruiting
Keimyung University - Dongsan Medical Center
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DaeguSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Kyungpook National University Hospital
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DaeguSouth KoreaRecruiting
Daegu Catholic University Medical Center
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DaeguSouth KoreaRecruiting
Chungnam National University Hospital
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DaejeonSouth KoreaRecruiting
Daejeon Eulji Medical Center
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DaejeonSouth KoreaRecruiting
National Health Insurance Service Ilsan Hospital
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GoyangSouth KoreaRecruiting
Dongguk University Ilsan Hospital
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GoyangSouth KoreaWithdrawn
Ilsan Paik Hospital
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GoyangSouth KoreaRecruiting
Hanyang University Guri Hospital
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Guri-siSouth KoreaRecruiting
Chosun University Hospital
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GwangjuSouth KoreaWithdrawn
Chonnam National University Hospital
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GwangjuSouth KoreaRecruiting
Chung-Ang University Gwangmyeong Hospital
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GwangmyeongSouth KoreaRecruiting
Dongtan Sacred Heart Hospital
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HwaseongSouth KoreaRecruiting
Wonkwang University Hospital
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IksanSouth KoreaRecruiting
Inha University Hospital
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IncheonSouth KoreaRecruiting
International St. Mary's Hospital
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IncheonSouth KoreaWithdrawn
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Jeju National University Hospital
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Jeju CitySouth KoreaRecruiting
Seoul National University Bundang Hospital
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SeongnamSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
National Medical Center
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SeoulSouth KoreaRecruiting
Gangnam Severance Hospital
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SeoulSouth KoreaRecruiting
Kyung Hee University Medical Center
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SeoulSouth KoreaRecruiting
Konkuk University Medical Center
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SeoulSouth KoreaRecruiting
Ewha Womans University Seoul Hospital
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SeoulSouth KoreaRecruiting
Severance hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Hallym University Kangdong Sacred Heart Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Yeouido St. Mary's Hospital
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SeoulSouth KoreaRecruiting
Hanyang University Seoul Hospital
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SeoulSouth KoreaRecruiting
Nowon Eulji Medical Center
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SeoulSouth KoreaRecruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
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SeoulSouth KoreaRecruiting
Ewha Womans University Mokdong Hospital
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SeoulSouth KoreaRecruiting
Chung ang University Hospital
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SeoulSouth KoreaRecruiting
Yongin Severance Hospital
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YŏnginSouth KoreaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.