NCT06595069已完成不适用
A Single-Center, Retrospective, Observational Study to Assess the Characteristics and the Real-World Long-Term Effectiveness of Inclisiran in Chinese Adult Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
研究概览
简要总结
This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting.
This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
时间窗: Baseline, Month 9
次要结局
- Change From Baseline to Month 9 in Triglyceride Levels(Baseline, Month 9)
- Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment(Up to 27 months)
- Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels(Baseline, Month 9)
- Change From Baseline to Month 9 in Total Cholesterol Levels(Baseline, Month 9)
- Change From Baseline to Month 9 in Apolipoprotein B Levels(Baseline, Month 9)
- Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels(Baseline, Month 9)
- Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels(Baseline, Month 9)
- Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels(Baseline, Month 9)
- Change From Baseline to Month 9 in Lipoprotein (a) Levels(Baseline, Month 9)
- Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran(Up to 27 months)
- Number of Patients With Changes in Lipid-lowering Therapies (LLTs)(Up to 27 months)
- Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months(12 months)
- Number of Patients per Demographic Category(Baseline)
- Number of Patients per Clinical Characteristic Category(Baseline)
- Baseline Lipid Levels(Baseline)
研究者
研究点 (1)
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