Intracranial Artery Stenosis
Conditions
Keywords
symptomatic intracranial atherosclerotic stenosis, stroke, blood lipid management, PCSK9 inhibitors
Brief summary
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
DRUGPCSK9 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
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment 3. low density lipoprotein cholesterol \> 70mg/dl (1.8mmol/L) 4. Receive 3T magnetic resonance angiography or multi-mode MR (high resolution is required), angiography can be included, and images for analysis can be obtained. 5. Lipid-lowering indications of statins 6. Signed an approved informed consents
Exclusion criteria
1. Contraindications to statins 2. There are contraindications to MRI examination or cannot accept MRI examination 3. Stenosis caused by vasculitis, arterial dissection and moyamoya disease 4. Patients with active bleeding or obvious bleeding tendency 5. 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 6. Uncontrolled severe diabetes and hypertension 7. Other conditions inappropriate for inclusion judged by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent stroke | 6 months-12 months | the recurrent rate of clinical stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracranial arterial | 6 months or 12 months | Degree of change in intracranial arterial stenosis |
| Plaque changes | 6 months or 12 months | Plaque volume and load changes |
| Vascular remodeling index | 6 months or 12 months | Vascular remodeling index changes |
| Adverse events | 6 months or 12 months | The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed |
Countries
China
Contacts
Primary ContactJunshan Zhou
Backup ContactQiwen Deng
Outcome results
None listed