NCT05697185尚未招募4 期
Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke
Second Affiliated Hospital of Guangxi Medical University0 个研究点目标入组 200 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Percent change in LDL-C
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between 18-80 years
- •Time of onset: within 1 week
- •NIHSS score ≤12
- •Acute ischemic stroke confirmed by head CT or MRI
- •Premorbid mRS ≤1
- •Signed informed consent
排除标准
- •Intracranial hemorrhage found by head CT
- •Severe hepatic or renal dysfunction
- •Pregnant females
- •Abnormal elevation of creatine phosphokinase
- •Blood sugar is out of control
- •Receiving statins within 1 month before onset
- •Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
- •Unsuitable for this clinical studies assessed by researcher
研究组 & 干预措施
the evolocumab plus statin therapy
Experimental
Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period
干预措施: Evolocumab (Drug)
结局指标
主要结局
Percent change in LDL-C
时间窗: baseline, 4 weeks, 8 weeks, 12 weeks after treatment
次要结局
- Vascular events(3 months, 6months)
- mRS (0-2)(3 months, 6months)
- death of any causes(12 months)
研究者
Junli Liang
Professor
Second Affiliated Hospital of Guangxi Medical University
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