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Optimal target LDL level for small vessel occlusion stroke: A multi-center, prospective, randomized, open-label, blinded endpoint trial (SVO70)

Optimal target LDL level for small vessel occlusion stroke: A multi-center, prospective, randomized, open-label, blinded endpoint trial (SVO70)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009043
Enrollment
4016
Registered
2023-12-14
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(LDL cholesterol control) : By random assignment, the subjects are assigned to one of the following two groups. - Active LDL cholesterol control group (LDL <70 mg/dL) - Standard treatment group

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged =19 years 2) Patients with small vessel occlusion stroke lesions that can be objectively identified by imaging *small vessel occlusion stroke lesions: The term is defined as the lesions of subcortical cerebral infarction or brainstem cerebral infarction, which can be identified in MRI images or CT (Computed Tomography) images, with a maximum diameter of =15 mm, and it belongs to the area where ischemic stroke due to small vessel occlusion can occur. 3) Patients with a history of symptomatic ischemic stroke caused by 2) lesions within 14 days of recruitment 4) Patients who voluntarily provide written consent after receiving an explanation of the study

Exclusion criteria

Exclusion criteria: 1) Patients whose ischemic stroke is likely to have occurred due to a cause other than small vessel occlusion 2) Patients with other medical conditions requiring LDL cholesterol management, and if the treatment guidelines for that condition specify LDL cholesterol control goals. 3) Patients who fall under the contraindications or precautions for statin therapy: those with active liver disease, serum transaminase levels elevated more than three times the normal range, neuromuscular disorders, hypersensitivity reactions to medications, or concurrent use of contraindicated drugs, etc. 4) Patients who are pregnant or breastfeeding, or who are expecting to become pregnant during the study period 5) Patients who are ineligible to continue participating in the trial for at least 2 years, based on the appraisal of at least one investigator

Design outcomes

Primary

MeasureTime frame
Major adverse cardiovascular event, MACE

Secondary

MeasureTime frame
Any stroke;Ischemic stroke or Transient ischemic attack;Cardiovascular death;Myocardial infarction;Any death;Acute coronary syndrome;New onset diabetes mellitus;Incidence of adverse events that occurred throughout clinical trials;Incidence of adverse drug reactions that are causally related to the administered drug;Incidence of serious adverse reactions;Incidence of adverse reactions by severity

Countries

Korea, Republic of

Contacts

Public ContactHyein Jeong

Seoul National University Hospital

jeonghi.cma@gmail.com+82-70-4352-2482

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 29, 2026