NCT05399992进行中（未招募）不适用
VICTORION REAL: An International Prospective Real-world Study to Evaluate the LDL-C changE and Adherence to incLisiran in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 847
- 试验地点
- 41
- 主要终点
- Percentage change in LDL-C from baseline to 10 months
研究概览
简要总结
This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.
详细描述
Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.
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
- •Participants who are 18 years or older
- •Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
- •Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
- •Participants who per physician's criteria need to optimize their LLT
- •Participants who provide written informed consent to participate in the study
- •Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.
排除标准
- •Participants that have received inclisiran previously
- •Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)
研究组 & 干预措施
Inclisiran cohort
Participants prescribed inclisiran alone or with other LLTs as per approved label
干预措施: Inclisiran (Other)
结局指标
主要结局
Percentage change in LDL-C from baseline to 10 months
时间窗: Baseline, 10 months
Percentage change in Low density lipoprotein - Cholesterol (LDL-C)
次要结局
- Percentage change in LDL-C from baseline(Baseline, month 4, month 16, month 22)
- Percentage change in LDL-C from baseline by ≥50%(Month 4, month 10, month 16, month 22)
- Percentage change in LDL-C from baseline by ≥30%(Month 4, month 10, month 16, month 22)
- Proportion of participants achieving LDL-C<55 mg/dL(Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22)
- Proportion of participants achieving LDL-C<70 mg/dL(Month 4, month 10, month 16 and month 22)
- Time-averaged percentage change in LDL-C from baseline(Baseline, month 4, month 10, month 16 and month 22)
- Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months(Month 10, month 16, month 22 and month 24)
- Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months(Baseline, month 10, month 24)
- Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months(Month 10 and month 24)
- Inclisiran cohort : Percentage of days covered by inclisiran(12 months and 24 months)
- Inclisiran cohort : Mean PDC(12 months and 24 months)
- Inclisiran cohort : Proportion of participants with a PDC ≥ 80%(12 months and 24 months)
- Proportion of participants remaining on initial baseline therapy(Baseline, month 12 and month 24)
- Time to discontinuation of any newly initiated therapies(Month 12 and month 24)
- Time to discontinuation of any newly initiated therapies by specific LLT(Month 12 and month 24)
- Change from baseline in scores from the TSQM (modified) instrument(Baseline, month 12 and month 24)
- Descriptive adherence data based on Adherence AAQ(Month 12 and month 24)
- Descriptive adherence data based on ABQ(Month 12 and month 24)
研究者
研究点 (41)
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