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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4016

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hanmi Pharmaceutical co., ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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