Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Description of adherence of treatment with alirocumab 300mg in a real-life Italian population.
研究概览
简要总结
Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients under alirocumab 300mg 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 Alirocumab 300 mg treatment.
Subjects with hyperlipidaemia
干预措施: Praluent (Alirocumab) (Drug)
结局指标
主要结局
Description of adherence of treatment with alirocumab 300mg in a real-life Italian population.
时间窗: 6-12-24-36 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 of treatment with alirocumab 300mg in a real-life Italian population.
时间窗: 6-12-24-36 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
Description of efficacy of treatment with alirocumab 300mg in a real-life Italian population.
时间窗: 6-12-24-36 months
Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value).
次要结局
- Description of safety of treatment with alirocumab 300mg in a real-life Italian population.(6-12-24-36 months)
研究者
Pasquale Perrone Filardi
Professor
Federico II University