A Belgian Registry to Evaluate the Real Life Treatment With Inclisiran on Top of Standard of Care Lipid-lowering Therapy in Patients With Atherosclerotic Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 16
- 主要终点
- Percentage of patients achieving the guideline-recommended LDL-C target at any time
研究概览
简要总结
This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected.
The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions.
详细描述
The study aims to assess the effectiveness, safety and adherence for Inclisiran in combination with lipid-lowering therapy (LLT) under conditions of routine clinical practice. The Inclisiran cohort will include patients receiving Inclisiran therapy as per the approved label independently of background Standard of Care (SoC) therapy. This study will include both primary data collection and secondary use of data.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 18 years or older.
- •Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible for commercially available Leqvio, as defined by the reimbursement criteria:
- •Patients with ASCVD documented by previous coronary heart disease (CHD), cerebrovascular disease or peripheral artery disease (PAD) and LDL-C ≥ 100mg/dL despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication).
- •Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients who have received Inclisiran previously.
- •Patients participating in a clinical trial with investigational product.
- •Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
研究组 & 干预措施
Inclisiran
Patients prescribed inclisiran on top of standard of care lipid-lowering therapy
干预措施: Inclisiran (Other)
结局指标
主要结局
Percentage of patients achieving the guideline-recommended LDL-C target at any time
时间窗: Up to 39 months
Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected
Mean percent change in LDL-C from baseline
时间窗: Baseline, up to 39 months
Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected
Mean absolute change in LDL-C from baseline
时间窗: Baseline, up to 39 months
Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
次要结局
- Number of injection site reactions(Up to 39 months)
- Change in LDL-C from baseline stratified on background therapy(Baseline, up to 39 months)
- Number of possibly related adverse events(Up to 39 months)
- Percentage of patients remaining on Inclisiran therapy at each injection visit(Up to 39 months)
- Percentage of patients with dose changes, switching, discontinuation(Up to 39 months)
- Number of patients with changes in Lp(a) levels for Inclisiran-treated patients(Up to 39 months)
- Percentage of patients maintaining the guideline-recommended LDL-C target(Up to 39 months)
- Time- adjusted percentage change in LDL-C from baseline(Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39)
- Number of ASCVD-related events(Up to 39 months)