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

May 17, 2025 updated by: Seung-Hoon Lee, Seoul National University Hospital

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, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4016

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Seung-Hoon Lee, MD, PhD
  • Phone Number: +82-2-2072-1014

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Recruiting
        • Korea University Ansan Hospital
      • Anyang, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
      • Busan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
      • Changwon, Korea, Republic of
        • Recruiting
        • Samsung Changwon Hospital
      • Changwon, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Changwon Hospital
      • Cheongju, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Recruiting
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Recruiting
        • Kyungpook National University Hospital
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of
        • Recruiting
        • Daejeon Eulji Medical Center
      • Goyang, Korea, Republic of
        • Recruiting
        • National Health Insurance Service Ilsan Hospital
      • Goyang, Korea, Republic of
        • Recruiting
        • Ilsan Paik Hospital
      • Goyang, Korea, Republic of
        • Recruiting
        • Dongguk University Ilsan Hospital
      • Guri, Korea, Republic of
        • Recruiting
        • Hanyang University Guri Hospital
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chosun University Hospital
      • Gwangmyeong, Korea, Republic of
        • Recruiting
        • Chung-Ang University Gwangmyeong Hospital
      • Hwaseong, Korea, Republic of
        • Recruiting
        • Dongtan Sacred Heart Hospital
      • Iksan, Korea, Republic of
        • Recruiting
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of
        • Recruiting
        • International St. Mary's Hospital
      • Jeju, Korea, Republic of
        • Recruiting
        • Jeju National University Hospital
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University MokDong Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Hallym University Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • National medical center
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Seoul Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Nowon Eulji Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
      • Yongin, Korea, Republic of
        • Recruiting
        • Yongin Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 informed consent

Exclusion Criteria:

  1. Patients requiring intensive LDL cholesterol management (LDL-C <70 mg/dL) due to another condition, with LDL cholesterol targets specified in the guidelines for that condition
  2. 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)
  3. Women who are pregnant, breastfeeding, or intending to become pregnant during the study period
  4. Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive group
Target LDL-cholesterol <70 mg/dL
Drug: Statins and/or Ezetimibe
Statin ± Ezetimibe to achieve target LDL-cholesterol level
Drug: PCSK9 inhibitor
The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.
Active Comparator: Standard group
Target LDL-cholesterol 90-110 mg/dL
Drug: Statins and/or Ezetimibe
Statin ± Ezetimibe to achieve target LDL-cholesterol level
Drug: PCSK9 inhibitor
The use of PCSK9 inhibitors is permitted to achieve target LDL-cholesterol levels in participants who did not reach the target with statins ± ezetimibe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular event
Time Frame: 4 years
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).
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction
Time Frame: 4 years
4 years
Any stroke
Time Frame: 4 years
Ischemic stroke, transient ischemic attack, or hemorrhagic stroke
4 years
Ischemic stroke or transient ischemic attack
Time Frame: 4 years
4 years
Cardiovascular death
Time Frame: 4 years
4 years
Any death
Time Frame: 4 years
4 years
Acute coronary syndrome
Time Frame: 4 years
ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Hanmi Pharmaceutical co., ltd.

Investigators

  • Principal Investigator: Seung-Hoon Lee, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2024

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 17, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2310-119-1479
  • KCT0009043 (Registry Identifier: CRIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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