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Clinical Trials in Spain / NCT06958315
Active, not recruiting Observational

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

NCT06958315 · tracked via the Priya Life Science Spain tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2025-06-16
Last updated
2026-08-07

Condition(s) studied

Atherosclerotic Vascular DiseaseHeterozygous Familial Hypercholesterolemia

Investigational drug(s) / intervention(s)

Inclisiran

Inclisiran: This is an observational study, there is no treatment allocation.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 outcome measure(s)

  • LDL-C levels - 12 months — 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.

Trial sites (20)

FacilityCityRegionStatus
Novartis Investigative Site Cadiz Andalusia
Novartis Investigative Site Granada Andalusia
Novartis Investigative Site Huelva Andalusia
Novartis Investigative Site Jaén Andalusia
Novartis Investigative Site Marbella Andalusia
Novartis Investigative Site Mallorca Balearic Islands
Novartis Investigative Site Puerto Real Cadiz
Novartis Investigative Site Santander Cantabria
Novartis Investigative Site Andújar Jaen
Novartis Investigative Site Logroño La Rioja
Novartis Investigative Site San Cristóbal de La Laguna Santa Cruz De Tenerife
Novartis Investigative Site Burgos Spain
Novartis Investigative Site Córdoba Spain
Novartis Investigative Site Fuerteventura Spain
Novartis Investigative Site Las Palmas GC Spain
Novartis Investigative Site León Spain
Novartis Investigative Site Málaga Spain
Novartis Investigative Site Salamanca Spain
Novartis Investigative Site Seville Spain
Novartis Investigative Site Seville Spain

On this site

📄 Leqvio (inclisiran) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06958315 on ClinicalTrials.gov ↗ ← All trials in Spain