Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- absolute change in LDL-C from baseline by months 1 and 3 of study therapy
研究概览
简要总结
To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.
详细描述
- Evaluate the efficacy and safety of lipid-lowering therapy in real clinical practice.
- To evaluate the efficacy and safety of pitavastatin in patients undergoing liver transplantation and receiving immunosuppressive therapy.
- Evaluate the efficacy and safety of PCSK9 inhibitors in patients undergoing liver transplantation and receiving immunosuppressive therapy.
- To compare the efficacy and safety of pitavastatin and a PCSK9 inhibitor in patients undergoing liver transplantation and receiving immunosuppressive therapy.
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
- Double (Investigator, 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
- •signed informed consent to participate in the study;
- •a history of liver transplantation for any reason;
- •immunosuppressive therapy;
- •the presence of hyperlipidemia, requiring the prescription of lipid-lowering therapy according to the clinical guidelines of the European Society for the Study of Atherosclerosis (EAS) 2019
- •failure to achieve the target level of LDL-C against the background of current lipid-lowering therapy;
- •if the patient within 1 month before randomization took lipid-lowering therapy, then the absence of side effects against the background of previous lipid-lowering therapy.
排除标准
- •treatment with PCSK9 in previous 6 months;
- •current treatment in the form of lipoprotein apheresis;
- •heart failure IV NYHA;
- •active infectious disease, severe hematological, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction) at the time of the screening or randomization visits;
- •the presence of an oncological disease, with the exception of hepatocellular carcinoma, which served as the reason for liver transplantation;
- •CFR<15ml/min/1,73m2;
- •pregnancy and breastfeeding.
研究组 & 干预措施
pitavastatin
Pitavastatin 2 mg/d - 4 mg/d
干预措施: Pitavastatin (Drug)
PCSK9 Inhibitors
Evolocumab 140 mg once per 2 weeks or Alirokumab 150 mg once per 2 weeks
干预措施: PCSK9 inhibitor (Drug)
结局指标
主要结局
absolute change in LDL-C from baseline by months 1 and 3 of study therapy
时间窗: months 1 and 3 of study therapy
absolute change in LDL-C from baseline
percent change in LDL-C from baseline at months 1 and 3 of study therapy
时间窗: months 1 and 3 of study therapy
percent change in LDL-C from baseline
the proportion of patients who have reached the target level of LDL-C by month 1 of study therapy
时间窗: month 1 of study therapy
the proportion of patients who have reached the target level of LDL-C
the proportion of patients who have reached the target level of LDL-C by month 3 of study therapy
时间窗: month 3 of study therapy
the proportion of patients who have reached the target level of LDL-C
次要结局
- the timing of achieving the target level of LDL-C at months 1, 3, 6, 7, 9, 12 of study therapy(months 1, 3, 6, 7, 9, 12 of study therapy)
- percent of patients with target level of LDL-C at months 6 and 12 of study therapy(months 6 and 12 of study therapy)