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
Status: Active_not_recruiting
Location: See all (19) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Aged ≥ 18 years.
• Written signed informed consent form (ICF).
• 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.
• 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.
Locations
Other Locations
Spain
Novartis Investigative Site
Andújar
Novartis Investigative Site
Burgos
Novartis Investigative Site
Cadiz
Novartis Investigative Site
Córdoba
Novartis Investigative Site
Fuerteventura
Novartis Investigative Site
Granada
Novartis Investigative Site
Huelva
Novartis Investigative Site
Jaén
Novartis Investigative Site
Las Palmas Gc
Novartis Investigative Site
Logroño
Novartis Investigative Site
Málaga
Novartis Investigative Site
Mallorca
Novartis Investigative Site
Marbella
Novartis Investigative Site
Puerto Real
Novartis Investigative Site
Salamanca
Novartis Investigative Site
San Cristóbal De La Laguna
Novartis Investigative Site
Santander
Novartis Investigative Site
Seville
Novartis Investigative Site
Seville
Time Frame
Start Date: 2025-06-16
Completion Date: 2027-05-01
Participants
Target number of participants: 198
Treatments
Inclisiran
Adults (≥18 years) with a confirmed clinical indication for inclisiran.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals