RecruitingNCT06958315
Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
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
Sponsor
Novartis Pharmaceuticals
Enrollment
200 participants
Start Date
Jun 16, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria5
- 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 Criteria1
- \. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.
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Interventions
OTHERInclisiran
This is an observational study, there is no treatment allocation.
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT06958315
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