Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
INSPIRE
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
1 other identifier
observational
200
1 country
20
Brief Summary
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 6, 2025
CompletedStudy Start
First participant enrolled
June 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 16, 2026
April 1, 2026
1.9 years
April 25, 2025
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-C levels - 12 months
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.
12 months following the initiation of inclisiran treatment.
Secondary Outcomes (13)
LDL-C levels - 6 months
6 months following the initiation of inclisiran treatment
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
- +8 more secondary outcomes
Study Arms (1)
Inclisiran
Adults (≥18 years) with a confirmed clinical indication for inclisiran.
Interventions
This is an observational study, there is no treatment allocation.
Eligibility Criteria
Adults (≥18 years) with a confirmed clinical indication for inclisiran.
You may qualify if:
- Aged ≥ 18 years.
- Written signed informed consent form (ICF).
- 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.
You may not qualify if:
- \. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Novartis Investigative Site
Cadiz, Andalusia, 11009, Spain
Novartis Investigative Site
Granada, Andalusia, 18014, Spain
Novartis Investigative Site
Huelva, Andalusia, 21005, Spain
Novartis Investigative Site
Jaén, Andalusia, 23007, Spain
Novartis Investigative Site
Marbella, Andalusia, 29600, Spain
Novartis Investigative Site
Mallorca, Balearic Islands, 07198, Spain
Novartis Investigative Site
Puerto Real, Cadiz, 11510, Spain
Novartis Investigative Site
Santander, Cantabria, 39008, Spain
Novartis Investigative Site
Andújar, Jaen, 23740, Spain
Novartis Investigative Site
Logroño, La Rioja, 26006, Spain
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Novartis Investigative Site
Burgos, 09006, Spain
Novartis Investigative Site
Córdoba, 14004, Spain
Novartis Investigative Site
Fuerteventura, 35600, Spain
Novartis Investigative Site
Las Palmas GC, 35010, Spain
Novartis Investigative Site
León, 24080, Spain
Novartis Investigative Site
Málaga, 29010, Spain
Novartis Investigative Site
Salamanca, 37007, Spain
Novartis Investigative Site
Seville, 41009, Spain
Novartis Investigative Site
Seville, 41013, Spain
Biospecimen
No samples will be retained.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 6, 2025
Study Start
June 16, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com