Short-term Effect of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor in Chinese Population With Acute Ischemic Stroke: the Singe-center Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- LDL-C target achievement rate on Day 5, Month 3
研究概览
简要总结
This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on improving cardiovascular events. However, existing studies have focused almost exclusively on the long-term effects of Evolocumab, and the early effects of Evolocumab on AIS patients remains unclear.
详细描述
Patients aged 18-80 years old admitted to the Department of Neurology, Xuanwu Hospital, Capital Medical University, with a definite diagnosis of acute ischemic stroke and receiving lipid-lowering therapy with statins with or without evolocumab will be included in this study. Participants will be divided into two groups according to the lipid-lowering therapy they used: 1) statin-alone group: the participants receive statins alone (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) for lipid reduction, and 2) PCSK9-i group: the participants receive statins (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) and evolocumab (140mg twice a month) for lipid reduction. Most importantly, the lipid-lowering therapy of participants will be decided only by clinicians not involved in the study, not by the investigators. The levels of blood lipid (TC, TG, HDL-C, LDL-C, Apo AI and Apo B) and inflammatory biomarkers (hsCRP and IL-6) of these participants at different time points (day 1, day 3, day 5, and month 3) will be recorded. The target level of LDL-C is the LDL-C reduction ≥50% from the baseline and LDL-C<1.4mmol/L (55mg/dL). In addition, the cardiovascular events and adverse drug reactions of these participants during follow-up will also be recorded. During the follow-up period (3 months), participants who changed their lipid-lowering regimen, including the type, dosage and frequency of statins and evolocumab, will be excluded from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute ischemic stroke;
- •Aged 18-80 years, gender unlimited;
- •The fasting LDL-C≥1.8mmol/L (70mg/dL);
- •Received lipid-lowering therapy with statins with or without evolocumab;
- •Premorbid mRS ≤ 2;
- •NIHSS ≤ 15;
- •Subjects participated in the study voluntarily and signed informed consent.
排除标准
- •Participants who changed their lipid-lowering regimen;
- •Participants allergic to PCSK9 inhibitors;
- •Participants treated with cholesterol ester transfer protein inhibitor within 12 months prior to enrollment;
- •LDL or plasma apheresis within 12 months prior to enrollment；
- •Last known left ventricular ejection fraction < 30%
- •Known hemorrhagic stroke at any time；
- •Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening；
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times；
- •Pregnant or lactating women；
- •Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.
研究组 & 干预措施
Statin-alone group
The participants in statin-alone group receive statins alone for lipid reduction.
干预措施: Statins (Drug)
PCSK9-i group
The participants in PCSK9-i group receive statins and evolocumab for lipid reduction.
干预措施: Statins (Drug)
PCSK9-i group
The participants in PCSK9-i group receive statins and evolocumab for lipid reduction.
干预措施: Evolocumab (Drug)
结局指标
主要结局
LDL-C target achievement rate on Day 5, Month 3
时间窗: Day 5, Month 3
LDL-C target achievement rate= Number of patients who achieved the LDL-C target level/ Total number of follow-up patients
次要结局
- Percentage change in hsCRP level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Incidence of adverse events on Month 3(Month 3)
- Percentage of mRS≤2 on Month 3(Month 3)
- Incidence of major cardiovascular events on Month 3(Month 3)
- Percentage change in LDL-C level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Percentage change in HDL-C level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Percentage change in TG level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Percentage change in IL-6 level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Percentage change in TC level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Percentage change in Apo AI level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)
- Percentage change in Apo B level on Day 1, Day 3, Day 5, and Month 3(Day 1, Day 3, Day 5, Month 3)