Clinical trial NCT06958315: Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atherosclerotic Vascular Disease
Heterozygous Familial Hypercholesterolemia
Keywords: inclisiran
Leqvio®
atherosclerotic vascular disease
heterozygous familial hypercholesterolemia
Spanish clinical practice
Spain
INSPIRE
LDL-C goal attaiment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥18 years) with a confirmed clinical indication for inclisiran.

Brief summary: This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years.
2. Written signed informed consent form (ICF).
3. 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.
4. 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.
5. Statin-intolerant patients are eligible if they had documented side effects on ≥2 statins, including one at the lowest dose.

Exclusion Criteria:

1. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.

Primary outcomes:
measure: LDL-C levels - 12 months
timeFrame: 12 months following the initiation of inclisiran treatment.
Secondary outcomes:
measure: LDL-C levels - 6 months
timeFrame: 6 months following the initiation of inclisiran treatment
measure: non-HLDL-C levels
timeFrame: 6 and 12 months following the initiation of inclisiran treatment
measure: Changes from baseline in LDL-C
timeFrame: Baseline, 3, 6, 9 and 12 months following the initiation of inclisiran treatment
measure: Frequency of AEs
timeFrame: From inclisiran initiation up to 12 months post-initiation
measure: Adherence rate to the concomitant LLT treatment
timeFrame: From 1st visit up to 12 months after inclisiran initiation
measure: Proportion of participants adhering to the prescribed inclisiran dosing schedule
timeFrame: From 1st visit up to 12 months after inclisiran initiation
measure: Inclisiran reasons for non-persistence
timeFrame: From 1st visit up to 12 months after inclisiran initiation
measure: Lp(a)
timeFrame: When available, from baseline up to 12 months after inclisiran initiation
measure: Changes in Lp(a)
timeFrame: From inclisiran initiation up to 12 months post-initiation
measure: Patient satisfaction with inclisiran, score on TSQM-II
timeFrame: 3 and at 12 months after treatment initiation.
measure: Specialty of the health care profesional prescribing inclisiran
timeFrame: From 1st visit up to 12 months after inclisiran initiation
measure: HCP who administers inclisiran
timeFrame: From 1st visit up to 12 months after inclisiran initiation
measure: Site of treatment administration for each dose
timeFrame: From 1st visit up to 12 months after inclisiran initiation
Other outcomes:
Locations:
Study officials:
References: