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Recruiting NCT05397405

Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome

No phase Interventional Intracranial Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCSK9 inhibitor.
Who it may be relevant to
Registry conditions: Intracranial Artery Stenosis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis（sICASBLM）

Overview

sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C\>1.8mmol/L) without endovascular therapy.

Detailed description

sICASBLM aims to determine the effectiveness of conventional lipid management combined with PCSK9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (LDL-C\>1.8mmol/L) without endovascular therapy.

Interventions

  • Drug PCSK9 inhibitor
    The aim is to improve blood lipid management by using atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months

Primary outcome measures

  • Recurrent stroke [Time frame: 6 months-12 months]
Secondary outcome measures (4)
  • Intracranial arterial [Time frame: 6 months or 12 months]
  • Plaque changes [Time frame: 6 months or 12 months]
  • Vascular remodeling index [Time frame: 6 months or 12 months]
  • Adverse events [Time frame: 6 months or 12 months]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment
  • low density lipoprotein cholesterol > 70mg/dl (1.8mmol/L)
  • Receive 3T magnetic resonance angiography or multi-mode MR (high resolution is required), angiography can be included, and images for analysis can be obtained.
  • Lipid-lowering indications of statins
  • Signed an approved informed consents

Exclusion criteria

  • Contraindications to statins
  • There are contraindications to MRI examination or cannot accept MRI examination
  • Stenosis caused by vasculitis, arterial dissection and moyamoya disease
  • Patients with active bleeding or obvious bleeding tendency
  • Severe heart, lung, renal insufficiency, malignant tumor or other malignant diseases, and death is highly likely within 7 days; pregnancy or women who are lactating
  • Uncontrolled severe diabetes and hypertension
  • Other conditions inappropriate for inclusion judged by investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Nanjing First Hospital, Nanjing Medical University — Nanjing
  • Nanjing First Hospital — Nanjing

Publications

  • Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026. PMID 42089099
  • Li Z, Liu X, Sun H, Jiang X, Zhang Y, Ji L, Zhang L, Wang M, Gu M, Li S, Zhang Y, Liu Y, Shi H, Jiang T, Mei Y, Zhu L, Zhou J, Deng Q. Predictors for recurrent ischemic stroke in patients with watershed infarct induced by intracranial artery stenosis. Clin Neurol Neurosurg. 2025 Jul;254:108897. doi: 10.1016/j.clineuro.2025.108897. Epub 2025 Apr 18. PMID 40288288

Identifiers

NCT: NCT05397405 · sICASBLM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗