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

Launched by NOVARTIS PHARMACEUTICALS · Apr 25, 2025

Keywords

ClinConnect Summary

The INSPIRE Study is a clinical trial looking at a medication called inclisiran (Leqvio®) for patients with certain heart and blood vessel conditions, specifically atherosclerotic vascular disease and heterozygous familial hypercholesterolemia. The goal of this study is to understand how inclisiran works in real-life situations in Spain, helping doctors make better treatment decisions for their patients. The trial is not yet recruiting participants, but it will focus on adults aged 18 and older who have already started inclisiran treatment at least two months before joining the study.

To be eligible, participants need to have a medical need for inclisiran and have had their bad cholesterol (LDL-C) levels checked within six months before starting the treatment. Those who are unable to tolerate statin medications due to side effects may also qualify. Participants will be asked to provide informed consent and will be monitored for their progress throughout the trial. This study is important because it aims to gather real-world data that can help improve treatment for people with high cholesterol and related heart conditions.

Gender

ALL

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.