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

Seoul National University

Status: Enrolling

Conditions: Ischemic Stroke; Small Vessel Cerebrovascular Disease; Cholesterol, LDL; Cardiovascular Diseases; Secondary Prevention

Treatments: Drug: Statins and/or Ezetimibe; Drug: PCSK9 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06649240

KCT0009043 (Registry Identifier)

H-2310-119-1479

Details and patient eligibility

About

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.

Enrollment: 4,016 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,016 participants in 2 patient groups

Intensive group

Experimental group

Description:

Target LDL-cholesterol \<70 mg/dL

Treatment:

Drug: PCSK9 inhibitor

Drug: Statins and/or Ezetimibe

Standard group

Active Comparator group

Description:

Target LDL-cholesterol 90-110 mg/dL

Treatment:

Drug: PCSK9 inhibitor

Drug: Statins and/or Ezetimibe