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Ischemic StrokeSVO70NCT06649240

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

A study testing Statins and/or Ezetimibe and PCSK9 inhibitor in people with Ischemic Stroke and Small Vessel Cerebrovascular Disease, run by Seoul National University Hospital at 46 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Statins and/or Ezetimibe and PCSK9 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,016 participants
Where
46 sitesSouth Korea
Study dates
4 Oct 2024to Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • 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.)
Show all 9Show fewer
  • 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)
  • 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

Trial locations and contacts

46 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wookjin Yang, MD, PhD contact

+82-70-4352-2482

ywj_2002@naver.com

Seung-Hoon Lee, MD, PhD contact

+82-2-2072-1014

46 sites in 1 country

South Korea46 sites, 43 recruiting

  • Korea University Ansan Hospital

    Ansan

    Recruiting

  • Hallym University Sacred Heart Hospital

    Anyang

    Recruiting

  • Pusan National University Hospital

    Busan

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Recruiting

  • Samsung Changwon Hospital

    Changwon

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon

    Recruiting

  • Kangwon National University Hospital

    Chuncheon

    Recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu

    Recruiting

  • Kyungpook National University Hospital

    Daegu

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Recruiting

  • Daejeon Eulji Medical Center

    Daejeon

    Recruiting

  • Dongguk University Ilsan Hospital

    Goyang

    Withdrawn

  • Ilsan Paik Hospital

    Goyang

    Recruiting

  • National Health Insurance Service Ilsan Hospital

    Goyang

    Recruiting

  • Hanyang University Guri Hospital

    Guri-si

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Recruiting

  • Chosun University Hospital

    Gwangju

    Withdrawn

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong

    Recruiting

  • Dongtan Sacred Heart Hospital

    Hwaseong

    Recruiting

  • Wonkwang University Hospital

    Iksan

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Recruiting

  • Inha University Hospital

    Incheon

    Recruiting

  • International St. Mary's Hospital

    Incheon

    Withdrawn

  • Jeju National University Hospital

    Jeju City

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam

    Recruiting

  • Asan Medical Center

    Seoul

    Recruiting

  • Chung-Ang University Hospital

    Seoul

    Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul

    Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul

    Recruiting

  • Gangnam Severance Hospital

    Seoul

    Recruiting

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Recruiting

  • Konkuk University Medical Center

    Seoul

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Recruiting

  • Kyung Hee University Medical Center

    Seoul

    Recruiting

  • National Medical Center

    Seoul

    Recruiting

  • Nowon Eulji Medical Center

    Seoul

    Recruiting

  • Samsung Medical Center

    Seoul

    Recruiting

  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center

    Seoul

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Severance Hospital

    Seoul

    Recruiting

  • Yeouido St. Mary's Hospital

    Seoul

    Recruiting

  • Yongin Severance Hospital

    Yŏngin

    Recruiting

Other trials in South Korea

About this study

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

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.

Being tested
Statins and/or Ezetimibe, PCSK9 inhibitor
Keywords
Cerebral Small Vessel Diseases, Ischemic Stroke, Secondary Prevention, Cholesterol, LDL, Statins
Medical subject headings
Ischemic Stroke, Cerebral Small Vessel Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Statins and/or EzetimibeDrug

    Statin ± Ezetimibe to achieve target LDL-cholesterol level

  • PCSK9 inhibitorDrug

    The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.

Study groups in NCT06649240
Study groupRoleWhat they receive
Intensive groupExperimentalTarget LDL-cholesterol <70 mg/dL
Receives: Drug: Statins and/or Ezetimibe; Drug: PCSK9 inhibitor
Standard groupActive comparatorTarget LDL-cholesterol 90-110 mg/dL
Receives: Drug: Statins and/or Ezetimibe; Drug: PCSK9 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 4 years

Secondary outcomes (7)

  1. Any stroke

    Ischemic stroke, transient ischemic attack, or hemorrhagic stroke

    Measured: 4 years

  2. Ischemic stroke or transient ischemic attack

    Measured: 4 years

  3. Cardiovascular death

    Measured: 4 years

  4. Myocardial infarction

    Measured: 4 years

  5. Any death

    Measured: 4 years

  6. Acute coronary syndrome

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

    Measured: 4 years

  7. Hemorrhagic stroke

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start4 Oct 2024
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,016 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06649240
Sponsor's protocol ID
H-2310-119-1479
Other IDs
KCT0009043
Acronym
SVO70
Status last verified
Sep 2026
First submitted
14 Oct 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Statins and/or Ezetimibe and PCSK9 inhibitor in people with Ischemic Stroke and Small Vessel Cerebrovascular Disease, run by Seoul National University Hospital at 46 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wookjin Yang, MD, PhD (+82-70-4352-2482, ywj_2002@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular event (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06649240, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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SVO70 Clinical Trial NCT06649240 | AzTrials