RecruitingNot Applicable

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

Spain200 participantsStarted 2025-06-16

Plain-language summary

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

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

LDL-C levels - 12 months

Timeframe: 12 months following the initiation of inclisiran treatment.

NCT IDNCT06958315

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05-01

Novartis Pharmaceuticals