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

Not Applicable

Recruiting

• Conditions: Ischemic Stroke; Small Vessel Cerebrovascular Disease; Cholesterol, LDL; Secondary Prevention; Cardiovascular Diseases
• Interventions: Drug: Statins and/or Ezetimibe; Drug: PCSK9 inhibitor

• Registration Number: NCT06649240
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-04
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-21
• Primary Completion: 2030-09
• Study Completion: 2030-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4016

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive group	Statins and/or Ezetimibe	Target LDL-cholesterol \<70 mg/dL
Intensive group	PCSK9 inhibitor	Target LDL-cholesterol \<70 mg/dL
Standard group	Statins and/or Ezetimibe	Target LDL-cholesterol 90-110 mg/dL
Standard group	PCSK9 inhibitor	Target LDL-cholesterol 90-110 mg/dL

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event	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 Outcome Measures

Name	Time	Method
Any death	4 years
Any stroke	4 years	Ischemic stroke, transient ischemic attack, or hemorrhagic stroke
Ischemic stroke or transient ischemic attack	4 years
Cardiovascular death	4 years
Myocardial infarction	4 years
Acute coronary syndrome	4 years	ST-elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina

Trial Locations

Locations (46)

National Health Insurance Service Ilsan Hospital; 🇰🇷 Goyang, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Samsung Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of

Hallym University Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

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