A Prospective Observational Study on the Effect of Improving Blood Lipid Management on the Clinical Prognosis of Symptomatic Intracranial Atherosclerotic Stenosis（sICASBLM）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Recurrent stroke
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months
干预措施: PCSK9 inhibitor (Drug)
Control group
Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months
结局指标
主要结局
Recurrent stroke
时间窗: 6 months-12 months
the recurrent rate of clinical stroke
次要结局
- Intracranial arterial(6 months or 12 months)
- Plaque changes(6 months or 12 months)
- Vascular remodeling index(6 months or 12 months)
- Adverse events(6 months or 12 months)