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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intracranial Artery Stenosis

Intervention / Treatment
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* Drug: PCSK9 inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months | Drug: PCSK9 inhibitor<br>* 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<br>* Other names: intensive blood lipid lowing;|
| No Intervention: Control group<br>Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke | the recurrent rate of clinical stroke | 6 months-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial arterial | Degree of change in intracranial arterial stenosis | 6 months or 12 months | 
| Plaque changes | Plaque volume and load changes | 6 months or 12 months | 
| Vascular remodeling index | Vascular remodeling index changes | 6 months or 12 months | 
| Adverse events | The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed | 6 months or 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic intracranial atherosclerotic stenosis, stroke, blood lipid management, PCSK9 inhibitors