Comparative Pilot Study of the Effectiveness of Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- decrease in LDL-cholesterol (mg/dl)
研究概览
简要总结
An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.
详细描述
STUDY DESIGN An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.
STUDY POPULATION The chosen population is constituted by patients belonging to the LDL-apheresis program of the General University Hospital Gregorio Marañón with the diagnosis of familial hypercholesterolemia and a history of cardiovascular disease.
Number of patients expected to participate in the study according to the base of patients treated with LDL-apheresis: 10.
STUDY DESIGN:
Non-controlled intervention study to evaluate the different therapies in the treatment of hypercholesterolemia, in which each patient will be self-controlled. The variables will be analyzed during different phases
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with age> 18 years
- •hypercholesterolemia with LDL-cholesterol> 100 mg / dl in treatment with the maximum dose tolerated by statins and a history of severe cardiovascular disease
- •patients who are included in the LDL-apheresis / biweekly program
排除标准
- •contraindications to receive evolocumab according to technical data.
- •hospital admission of any cause in the last three months prior to the inclusion of the study
- •cardiovascular event in the three months prior to the inclusion of the study
- •Inability to sign informed consent
- •pregnant women and non-menopausal women who do not use at least one adequate contraceptive method
研究组 & 干预措施
LDL apheresis
LDL apheresis during at least one year
干预措施: LDL apheresis (Procedure)
Evolocumab
140 mg evolocumab biweekly
干预措施: evolocumab (Drug)
LDL apheresis and evolocumab
LDL-apheresis monthly evolocumab 140 mg biweekly
干预措施: evolocumab and LDL apheresis (Drug)
结局指标
主要结局
decrease in LDL-cholesterol (mg/dl)
时间窗: 9 months
decrease in LDL-cholesterol levels in all three phases: LDL-apheresis, evolocumab and combined
次要结局
- Modification of immunoglobulin A levels (mg/dl)(9 months)
- Decrease in triglycerides (mg/dl) levels(9 months)
- Modification of immunoglobulin G levels (mg/dl)(9 months)
- Decrease apo-B (mg/dl) levels(9 months)
- Decrease lipoprotein A (mg/dl) levels(9 months)
- any adverse effects(9 months)
- Modification of serum fibrinogen (mg/dl)(9 months)
- Modification of C reactive protein(9 months)
- Modification of complement levels (mg/dl)(9 months)
研究者
Marían Goicoechea
MD, PhD
Hospital General Universitario Gregorio Marañon