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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

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, baseline LDL-cholesterol \<70 mg/dL in the absence of lipid-lowering therapy, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Extracranial or intracranial large artery stenosis ≥50%

History of atherosclerotic ischemic stroke or transient ischemic attack

Documented coronary artery disease

Documented peripheral artery disease or aortic atherosclerotic disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

4,016 Participants
are divided into 2 treatment groups
Group A: Intensive groupExperimental treatment 2 interventions
Group B: Standard groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular event

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).

Time frame
4 years

Secondary outcomes

1

Any stroke

Ischemic stroke, transient ischemic attack, or hemorrhagic stroke

Time frame
4 years
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Hanmi Pharmaceutical co., ltd.

Collaborator