ClinicalTrials.gg
RecruitingNCT06649240SVO70Updated Sep 11, 2026

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

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

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,016
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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 \<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.

02

Conditions studied

  • Ischemic Stroke
  • Small Vessel Cerebrovascular Disease
  • Cholesterol, LDL
  • Secondary Prevention
  • Cardiovascular Diseases

Keywords

  • Cerebral Small Vessel Diseases
  • Ischemic Stroke
  • Secondary Prevention
  • Cholesterol, LDL
  • Statins
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 4,016 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  1. Extracranial or intracranial large artery stenosis ≥50%
  2. History of atherosclerotic ischemic stroke or
  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 \<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 for statin use (e.g., active liver disease, serum transaminase levels elevated more than three times the normal limit, muscle disorders, 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
4,016 participants (estimated)

Study arms

  • Experimental
    Intensive group

    Target LDL-cholesterol \<70 mg/dL

    Drug: Statins and/or Ezetimibe · Drug: PCSK9 inhibitor

  • Active comparator
    Standard group

    Target LDL-cholesterol 90-110 mg/dL

    Drug: Statins and/or Ezetimibe · Drug: PCSK9 inhibitor

Interventions

  • DrugStatins and/or Ezetimibe

    Drug pages: Statins · Ezetimibe

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Any stroke

    Ischemic stroke, transient ischemic attack, or hemorrhagic stroke

    Time frame: 4 years

  2. Ischemic stroke or transient ischemic attack

    Time frame: 4 years

  3. Cardiovascular death

    Time frame: 4 years

  4. Myocardial infarction

    Time frame: 4 years

  5. Any death

    Time frame: 4 years

  6. Acute coronary syndrome

    ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina

    Time frame: 4 years

  7. Hemorrhagic stroke

    Time frame: 4 years

07

Study locations

43 of 46 sites recruiting
08

References and documents

Publications

  • Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35. PubMed 7678184 ↗
  • Amarenco P, Benavente O, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, Gilbert S, Rudolph AE, Simunovic L, Zivin JA, Welch KM; Stroke Prevention by Aggressive Reduction in Cholesterol Levels Investigators. Results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial by stroke subtypes. Stroke. 2009 Apr;40(4):1405-9. doi: 10.1161/STROKEAHA.108.534107. Epub 2009 Feb 19. PubMed 19228842 ↗
  • Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23. PubMed 37236211 ↗
  • Goldstein LB, Amarenco P, Szarek M, Callahan A 3rd, Hennerici M, Sillesen H, Zivin JA, Welch KM; SPARCL Investigators. Hemorrhagic stroke in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels study. Neurology. 2008 Jun 10;70(24 Pt 2):2364-70. doi: 10.1212/01.wnl.0000296277.63350.77. Epub 2007 Dec 12. PubMed 18077795 ↗
  • Mok V, Kim JS. Prevention and Management of Cerebral Small Vessel Disease. J Stroke. 2015 May;17(2):111-22. doi: 10.5853/jos.2015.17.2.111. Epub 2015 May 29. PubMed 26060798 ↗
  • Hosomi N, Nagai Y, Kohriyama T, Ohtsuki T, Aoki S, Nezu T, Maruyama H, Sunami N, Yokota C, Kitagawa K, Terayama Y, Takagi M, Ibayashi S, Nakamura M, Origasa H, Fukushima M, Mori E, Minematsu K, Uchiyama S, Shinohara Y, Yamaguchi T, Matsumoto M; J-STARS Collaborators. The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study. EBioMedicine. 2015 Aug 6;2(9):1071-8. doi: 10.1016/j.ebiom.2015.08.006. eCollection 2015 Sep. PubMed 26501105 ↗
  • Amarenco P, Bogousslavsky J, Caplan LR, Donnan GA, Wolf ME, Hennerici MG. The ASCOD phenotyping of ischemic stroke (Updated ASCO Phenotyping). Cerebrovasc Dis. 2013;36(1):1-5. doi: 10.1159/000352050. Epub 2013 Jul 30. PubMed 23899749 ↗
  • Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Bejot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallee PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touze E, Varenne O, Vicaut E, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18. PubMed 31738483 ↗
  • Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available. PubMed 34024117 ↗
  • Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59. doi: 10.1056/NEJMoa061894. PubMed 16899775 ↗
  • Kim JY, Kang K, Kang J, Koo J, Kim DH, Kim BJ, Kim WJ, Kim EG, Kim JG, Kim JM, Kim JT, Kim C, Nah HW, Park KY, Park MS, Park JM, Park JH, Park TH, Park HK, Seo WK, Seo JH, Song TJ, Ahn SH, Oh MS, Oh HG, Yu S, Lee KJ, Lee KB, Lee K, Lee SH, Lee SJ, Jang MU, Chung JW, Cho YJ, Choi KH, Choi JC, Hong KS, Hwang YH, Kim SE, Lee JS, Choi J, Kim MS, Kim YJ, Seok J, Jang S, Han S, Han HW, Hong JH, Yun H, Lee J, Bae HJ. Executive Summary of Stroke Statistics in Korea 2018: A Report from the Epidemiology Research Council of the Korean Stroke Society. J Stroke. 2019 Jan;21(1):42-59. doi: 10.5853/jos.2018.03125. Epub 2018 Dec 18. PubMed 30558400 ↗
  • Yang W, Song TJ, Koh SH, Jeong HS, Sohn SI, Kim YS, Kim BJ, Jung JM, Jung KH, Kim JM, Jang H, Lee EJ, Chung M, Kim S, Park HK, Yu S, Cho YJ, Kim JT, Kim Y, Kim C, Kim HY, Oh MS, Kim DH, Lee YB, Eun MY, Park HY, Kang K, Kwon HM, Cho HJ, Kim JG, Choi JC, Yoo J, Nam HS, Ok T, Cho AH, Lee JY, Shin JY, Park JH, Park KY, Shin DI, Do Y, Chang Y, Jung S, Jung YH, Seo WK, Jeong SW, Ha SY, An SJ, Ahn SH, Hwang YH, Lee SH. SVO70 (Optimal Target Low-Density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke): Rationale and Study Design. J Am Heart Assoc. 2026 May 5;15(9):e046824. doi: 10.1161/JAHA.125.046824. Epub 2026 Apr 28. PubMed 42047198 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06649240
Collaborators
Hanmi Pharmaceutical co., ltd.
Responsible party
Seung-Hoon Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 18, 2024
Start date
Oct 4, 2024
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Sep 11, 2026

Study contacts

Wookjin Yang, MD, PhD
Contact
ywj_2002@naver.com
+82-70-4352-2482
Seung-Hoon Lee, MD, PhD
Contact
+82-2-2072-1014
Seung-Hoon Lee, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Statins · Ezetimibe · PCSK9 Inhibitor

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