An Observational Prospective Study to Assess the Effectiveness of Inclisiran(Leqvio®)in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spanish Clinical Practice:the INSPIRE Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 219
- 试验地点
- 20
- 主要终点
- LDL-C levels - 12 months
研究概览
简要总结
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
详细描述
The objective of the study is to determine the proportion of Atherosclerotic cardiovascular disease (ASCVD) and/or Heterozygous Familial Hypercholesterolemia (HeFH) patients reaching low-density lipoprotein-cholesterol (LDL-C) goals according to their cardiovascular risk at 12 months after the initiation of inclisiran treatment.
The study also aims to evaluate changes in LDL-C levels, safety profile, adherence and persistence to inclisiran treatment, use of concomitant lipid-lowering therapy (LLT), and patient satisfaction with inclisiran among other variables collected in clinical practice.
This is a non-interventional, prospective, multicentric, and nationwide study that will be conducted in routine clinical practice in Spain. This study will consist of three visits, coinciding with those conducted as part of the patients' routine follow-up, without interfering with the clinical practice of the participating centers. A blood test to assess LDL-C levels will be conducted at 3, 6, 9 and 12 months after inclisiran initiation, according to clinical practice.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years.
- •Written signed informed consent form (ICF).
- •Patients with a confirmed clinical indication for inclisiran who have received the first dose of inclisiran, following clinical judgement, at least 2 months prior to the inclusion in the study.
- •Available assessment of LDL-C levels (mg/dL) within 6 months before inclisiran initiation. The measurement of LDL-C levels must be done after one month of stable LLT and without any modification from the testing up to inclisiran initiation.
- •Statin-intolerant patients are eligible if they had documented side effects on ≥2 statins, including one at the lowest dose.
排除标准
- •1. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.
研究组 & 干预措施
Inclisiran
Adults (≥18 years) with a confirmed clinical indication for inclisiran.
干预措施: Inclisiran (Other)
结局指标
主要结局
LDL-C levels - 12 months
时间窗: 12 months following the initiation of inclisiran treatment.
Proportion of participants reaching guideline-established low densitiy lipoprotein-Cholesterol (LDL-C) targets according to their Cardiovascular (CV) risk * LDL-C \<55 mg/dL for ASCVD participants. * LDL-C \<70 mg/dL for HeHF patients.
次要结局
- LDL-C levels - 6 months(6 months following the initiation of inclisiran treatment)
- Changes in Lp(a)(From inclisiran initiation up to 12 months post-initiation)
- non-HLDL-C levels(6 and 12 months following the initiation of inclisiran treatment)
- Changes from baseline in LDL-C(Baseline, 3, 6, 9 and 12 months following the initiation of inclisiran treatment)
- Frequency of AEs(From inclisiran initiation up to 12 months post-initiation)
- Adherence rate to the concomitant LLT treatment(From 1st visit up to 12 months after inclisiran initiation)
- Proportion of participants adhering to the prescribed inclisiran dosing schedule(From 1st visit up to 12 months after inclisiran initiation)
- Inclisiran reasons for non-persistence(From 1st visit up to 12 months after inclisiran initiation)
- Lp(a)(When available, from baseline up to 12 months after inclisiran initiation)
- Patient satisfaction with inclisiran, score on TSQM-II(3 and at 12 months after treatment initiation.)
- Specialty of the health care profesional prescribing inclisiran(From 1st visit up to 12 months after inclisiran initiation)
- HCP who administers inclisiran(From 1st visit up to 12 months after inclisiran initiation)
- Site of treatment administration for each dose(From 1st visit up to 12 months after inclisiran initiation)