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Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study

NCT06958315

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Atherosclerotic Vascular Disease, Heterozygous Familial Hypercholesterolemia

Interventions: Inclisiran

Countries: Spain

This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Aged ≥ 18 years.
2. Written signed informed consent form (ICF).
3. 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.
4. 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.
5. Statin-intolerant patients are eligible if they had documented side effects on ≥2 statins, including one at the lowest dose.

Exclusion Criteria:

1\. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.

Locations (20)

Cadiz, Andalusia, Spain
Granada, Andalusia, Spain
Huelva, Andalusia, Spain
Jaén, Andalusia, Spain
Marbella, Andalusia, Spain
Mallorca, Balearic Islands, Spain
Puerto Real, Cadiz, Spain
Santander, Cantabria, Spain
Andújar, Jaen, Spain
Logroño, La Rioja, Spain
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Burgos, Spain
Córdoba, Spain
Fuerteventura, Spain
Las Palmas GC, Spain
León, Spain
Málaga, Spain
Salamanca, Spain
Seville, Spain
Seville, Spain