Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The TG levels on the 3rd and 7th days after treatment
研究概览
简要总结
The severity of hypertriglyceridemia induced acute pancreatitis (HTG-AP) is closely related to the serum triglyceride (TG) levels. The higher the TG levels, the greater the risk of developing severe acute pancreatitis (SAP). Previous expert consensus has pointed out that the key to treating HTG-AP is to rapidly lower serum TG levels to below 5.65 mmol/L. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which is often used to treat familial hypercholesterolemia, mixed dyslipidemia and atherosclerotic cardiovascular disease. At the same time, evolocumab also has the effect of reducing TG and may provide a feasible option for the management of HTG-AP. However, its efficacy and safety in reducing TG in patients with HTG-AP remain controversial. This study is a multicenter randomized controlled trial to evaluate the efficacy and safety of adding evolocumab to conventional lipid-lowering therapy in patients with HTG-AP.
详细描述
Overall, 40 patients with HTG-AP will be included. These patients will be randomly assigned in a 1:1 ratio to the conventional lipid-lowering therapy group and the conventional lipid-lowering therapy + evolocumab group. The primary endpoints are the TG levels at days 3 and 7 after treatment, and the rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L at the same time points. Secondary endpoints include blood levels of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and lipoprotein(a) at days 3 and 7; the incidence of recurrent acute pancreatitis (RAP), SAP, and other complications; as well as the length of hospital stay and total hospitalization costs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~75 years
- •Patients with HTG-AP
- •Mixed hyperlipidemia
- •Sign the informed consent form
排除标准
- •Patients who have received lipid-lowering drugs or blood purification treatment
- •Patients who have used evolocumab within one month before admission
- •Patients who are accompanied by diseases that can seriously affect the survival
- •Patients who have participated in the clinical research of other drugs within one month
- •Patients who are pregnant or breastfeeding
- •Patients with allergic asthma, allergic urticaria, eczema, and those who have a clear history of multiple drug and food allergies
- •Other circumstances that researchers consider not suitable for participation in this study
研究组 & 干预措施
Conventional lipid-lowering therapy group
干预措施: Conventional lipid-lowering therapy (Drug)
Conventional lipid-lowering therapy + Evolocumab group
干预措施: Evolocumab 140 MG/ML [Repatha] (Drug)
结局指标
主要结局
The TG levels on the 3rd and 7th days after treatment
时间窗: 3 days and 7days
The rates of achieving TG levels below 5.65 mmol/L and 1.7 mmol/L on the 3rd and 7th days after treatment
时间窗: 3 days and 7 days
次要结局
- The serum levels of TC, HDL, LDL, and lipoprotein(a) on the 3rd and 7th days after treatment(3 days and 7days)
- The incidence of RAP, SAP, and other complications(6 months)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region