Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06649240

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Statins and/or Ezetimibe

Drug

Statin ± Ezetimibe to achieve target LDL-cholesterol level

PCSK9 inhibitor

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Any stroke

    Time frame: 4 years

    Ischemic stroke, transient ischemic attack, or hemorrhagic stroke

  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

    Time frame: 4 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Seung-Hoon Lee, MD, PhD

CONTACT

+82-2-2072-1014

Wookjin Yang, MD, PhD

CONTACT

[email protected]

+82-70-4352-2482

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hanmi Pharmaceutical co., ltd.

Registry information

Official study title

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

Acronym: SVO70

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 18, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.