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临床试验/NCT03110432
NCT03110432已完成不适用

Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

GWT-TUD GmbH3 个研究点 分布在 1 个国家目标入组 1,695 人开始时间: 2017年5月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
GWT-TUD GmbH
入组人数
1,695
试验地点
3
主要终点
LDL cholesterol goal achievement

研究概览

简要总结

This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.

详细描述

The study is purely observational, and will document data from the patient charts only. Treatment of patients will not be changed by this study, and all clinical decisions (including on frequency of visits) will be upon the discretion of the physician. No blood samples must be taken solely for the purpose of the study.

The registry will include two types of centers: 1) office-based cardiologists and 2) specialized lipid ambulances (outpatient departments).

Data on patient disease and treatment history will be collected a first documentation (retrospectively).

The documentation time is 3 years per patient. After the baseline visit, patients are followed-up every 6 ± 2months (last visit at month 36). This interval is considered narrow enough not to miss important events (safety reporting, cardiovascular events, hospitalizations).

Patients with stable (maintenance) lipid-lowering therapy (including those with existing PCSK9i therapy) or those with any therapy changes (including newly initiated PCSK9i treatment) will be documented in this study. Compared to the former group with stable drug treatment, the latter group will likely have major LDL-C changes during the first few weeks, which will be accounted for by (retrospective) monthly documentation in the first 3 months (data will be documented at the 6-month visit.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or
  • with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or
  • with heterozygous familial or non- familial hypercholesterolemia or mixed dyslipidemia with
  • therapy refractory course
  • maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period
  • unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis)
  • confirmed vascular disease
  • other risk factors for cardiovascular events

排除标准

  • Concurrent participation of the patient in a clinical randomised study.

研究组 & 干预措施

Standard lipid lowering therapy

Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents)

干预措施: Standard lipid lowering therapy (Drug)

PCSK9 Inhibitor [EPC]

Evolocumab or alirocumab.

干预措施: PCSK9 Inhibitor [EPC] (Drug)

结局指标

主要结局

LDL cholesterol goal achievement

时间窗: 3 years

\< 70 mg/dl

次要结局

  • LDL cholesterol reduction(up top 3 years)
  • Number of treatment changes(up to 3 years)

研究者

发起方
GWT-TUD GmbH
申办方类型
Other
责任方
Sponsor

研究点 (3)

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