Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study

Novartis

Status: Enrolling

Conditions: Heterozygous Familial Hypercholesterolemia; Atherosclerotic Vascular Disease

Treatments: Other: Inclisiran

Study type: Observational

Funder types: Industry

Identifiers

NCT06958315

CKJX839A1ES03

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Inclisiran

Description:

Adults (≥18 years) with a confirmed clinical indication for inclisiran.

Treatment:

Other: Inclisiran