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: Recruiting
Location: See all (7) 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
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Granada
Novartis Investigative Site
RECRUITING
Huelva
Novartis Investigative Site
RECRUITING
Jaén
Novartis Investigative Site
RECRUITING
Las Palmas De Gran Canaria
Novartis Investigative Site
RECRUITING
Logroño
Novartis Investigative Site
RECRUITING
Seville
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Inclisiran
Adults (≥18 years) with a confirmed clinical indication for inclisiran.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals