A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting (VICTORION-Implement)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,868
- 试验地点
- 118
- 主要终点
- Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted
研究概览
简要总结
This is a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral Lipid lowering treatment on top of a statin (Oral LLT cohort), newly initiated Inclisiran (Inclisiran cohort) and newly initiated Inclisiran on top of lipid apheresis (Apheresis plus Inclisiran cohort) in routine clinical care. All procedures, treatment adaptions and laboratory assessments are part of clinicla routine and conducted independent of this study.
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
- 否
入选标准
- •Patients who provide written informed consent to participate in the study
- •Male or female patients ≥ 18 years of age
- •Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin) or new oral LLT alone in case of statin intolerance or contraindication
- •Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
- •Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).
排除标准
- •Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
- •Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
- •Contraindication for Inclisiran according to the SmPC
- •Patients who have received Inclisiran previously
- •Patients with homozygous FH
- •Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- •Simultaneous or planned participation in an interventional research study
研究组 & 干预措施
Oral LLT
Patients with documented ASCVD not at individual LDL-C goal and newly initiated on an oral lipid lowering treatment on top of a statin, or alone in patients who are statin-intolerant, or for whom a statin is contraindicated
Inclisiran
Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at their individual LDL-C goal as per their CV risk. Two individual sub-cohorts are analysed: 1. Inclisiran in a PCSK9-treatment naive cohort 2. Inclisiran in patients with prior PCSK9 antibody treatment
干预措施: Inclisiran (Other)
Apheresis plus Inclisiran
Patients who newly initiated Inclisiran on top of lipid apheresis
干预措施: Inclisiran (Other)
结局指标
主要结局
Apheresis plus Inclisiran Cohort: Number of lipid apheresis conducted
时间窗: Baseline
Number of lipid apheresis conducted on Apheresis plus Inclisiran cohort is collected
Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis
时间窗: Baseline
Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis is collected
Number of patients with cardiovascular events
时间窗: Baseline
Number of patients with cardiovascular events is collected
Number of apheresis treatments in the previous 12 months
时间窗: Baseline
Number of apheresis treatments in the previous 12 months is collected
Number of participants with concomitant medication in the previous 12 months
时间窗: Baseline
Number of participants with concomitant medication in the previous 12 months is collected
Lipid lowering therapy used in the previous 12 months
时间窗: Baseline
Lipid lowering therapy used in the previous 12 months is collected
Low Density Lipoprotein cholesterol (LDL-C)
时间窗: Baseline
Low Density Lipoprotein cholesterol (LDL-C) is collected
次要结局
- Apheresis plus Inclisiran Cohort: Changes in PTH(Baseline, month 3, month 9, month 15, month 21)
- Percentage of patients who discontinue Inclisiran/ any LLT(21 months)
- Change in LDL-C compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Changes in TC, HDL-C and non-HDL-C compared to Baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in c-reactive protein compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Changes in triglycerides and LP(a) compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in hsCRP compared to Baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in Creatinin compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in eGFR compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Proportion of patients achieving prespecified LDL-C targets(Baseline, month 3, month 9, month 15, month 21)
- Changes in SMART-Risk Scores over time compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Changes from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time(Baseline, month 3, month 9, month 15, month 21)
- Percentage of Adverse Events and Serious Adverse Events(21 months)
- Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy(21 months)
- Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis(12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21)
- Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time(21 months)
- Percentage of days covered by at least one LLT(21 months)
- Percentage of patients with a PDC ≥ 80% months(21 months)
- Time to discontinuation of Inclisiran/ any LLT(21 months)
- Number of In- and outpatient visits(21 months)
- Number of consultations(21 months)
- Percentage of patients with a PDC ≥ 80% months(21 months)
- Percentage of patients who discontinue Inclisiran/ any LLT(21 months)
- Number of examinations(21 months)
- Changes in triglycerides and LP(a) compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in hsCRP compared to Baseline(Baseline, month 3, month 9, month 15, month 21)
- Proportion of patients achieving prespecified LDL-C targets(Baseline, month 3, month 9, month 15, month 21)
- Percentage of patients achieving ≥50% LDL-C reduction over time(Baseline, month 3, month 9, month 15, month 21)
- Number and types of lipid lowering treatments(21 months)
- Inclisiran Cohort: Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time(21 months)
- Percentage of days covered by at least one LLT(21 months)
- Time to discontinuation of Inclisiran/ any LLT(21 months)
- Change in LDL-C compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Changes in TC, HDL-C and non-HDL-C compared to Baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in c-reactive protein compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in Creatinin compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in HbA1c compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Change in eGFR compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Changes in SMART-Risk Scores over time compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Proportion of patients with treatment modifications(21 months)
- Changes from baseline in TSQM-9 over time(Baseline, month 3, month 9, month 15, month 21)
- Changes from baseline in WHO Quality of Life BREF (WHOQOL-BRED)questionnaire over time(Baseline, month 3, month 9, month 15, month 21)
- Apheresis plus Inclisiran Cohort: Changes in CRP compared to baseline(Baseline, month 3, month 9, month 15, month 21)
- Evaluate nutritional factors via questionnaire(Baseline, month 3, month 9, month 15, month 21)
- Percentage of Adverse Events and Serious Adverse Events(21 months)
- Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy(21 months)
- Apheresis plus Inclisiran Cohort: Changes in the rate of lipid apheresis(12 months pre-Baseline, Baseline, month 3, month 9, month 15, month 21)
- Apheresis plus Inclisiran Cohort: Changes in PTH(Baseline, month 3, month 9, month 15, month 21)