Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - CHOLINET (CHOLesterol Italian Inclisiran NETwork)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Description of adherence to treatment with Inclisiran in a real-life Italian population
研究概览
简要总结
Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 under Inclisiran treatment
排除标准
- •Age < 18 years o > 80 years
- •Patients who refuse to participate and to sign informed consent
研究组 & 干预措施
Subjects with hyperlipidaemia under Inclisiran treatment
干预措施: Inclisiran (Drug)
结局指标
主要结局
Description of adherence to treatment with Inclisiran in a real-life Italian population
时间窗: 3-6-12 months
Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself.
Description of persistence to treatment with Inclisiran in a real-life Italian population
时间窗: 3-6-12 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Description of efficacy of treatment with Inclisiran in a real-life Italian population
时间窗: 3-6-12 months
Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value). The deltaLDL will be calculated as an overall (mean and median value), by type of prevention (primary and secondary), by type of basic therapy, by demographic variables (age, sex, geographic origin, basal LDL levels) and by type of prescriber (hospital or territorial).
次要结局
未报告次要终点
研究者
Pasquale Perrone Filardi
Professor
Federico II University