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

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0009043

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 4016

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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event, MACE

Secondary Outcome Measures

Name	Time	Method
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