Clinical trial

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

Name
sICASBLM
Description
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.
Trial arms
Trial start
2022-05-23
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Recruiting
Treatment
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
Arms:
Intervention group
Other names:
intensive blood lipid lowing
Size
180
Primary endpoint
Recurrent stroke
6 months-12 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2023-07-24

1 organization

1 product

1 indication