Status:
RECRUITING
Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atherosclerotic Vascular Disease
Heterozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18-99 years
Brief Summary
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
Detailed Description
The objective of the study is to determine the proportion of Atherosclerotic cardiovascular disease (ASCVD) and/or Heterozygous Familial Hypercholesterolemia (HeFH) patients reaching low-density lipop...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.
Key Trial Info
Start Date :
June 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06958315
Start Date
June 16 2025
End Date
December 31 2026
Last Update
December 30 2025
Active Locations (16)
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1
Novartis Investigative Site
Cadiz, Andalusia, Spain, 11009
2
Novartis Investigative Site
Granada, Andalusia, Spain, 18014
3
Novartis Investigative Site
Huelva, Andalusia, Spain, 21005
4
Novartis Investigative Site
Jaén, Andalusia, Spain, 23007