Inclisiran (Leqvio®) to lower LDL‑cholesterol in people in Spain with atherosclerotic vascular disease or heterozygous familial hypercholesterolemia

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

We will try inclisiran (Leqvio®) in adults in Spain with atherosclerotic vascular disease or heterozygous familial hypercholesterolemia to see if they reach LDL‑cholesterol goals over 12 months in routine care.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 20 sites (Cadiz, Andalusia and 19 other locations)
• Trial ID: NCT06958315 on ClinicalTrials.gov

What this trial studies

This is a prospective, non‑interventional, multicenter observational study conducted in routine clinical practice in Spain that follows patients already started on inclisiran. Patients will have follow‑up visits aligned with routine care and LDL‑cholesterol measurements planned at approximately 3, 6, 9 and 12 months after inclisiran initiation. The primary objective is to determine the proportion of patients who reach LDL‑C goals at 12 months; secondary data include changes in LDL‑C, safety, adherence and persistence, concomitant lipid‑lowering therapies, and patient satisfaction. No investigational procedures beyond routine blood tests and visits are imposed, and inclusion requires a baseline LDL‑C measurement taken within six months before starting inclisiran.

Who should consider this trial

Good fit: Adults (≥18 years) in Spain with confirmed atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia who have received their first dose of inclisiran at least 2 months before enrollment and have a recent baseline LDL‑C measurement are ideal candidates, including statin‑intolerant patients with documented intolerance to ≥2 statins.

Not a fit: Patients taking part in other interventional trials that could change LDL‑C, those who have not started inclisiran, or those without a reliable baseline LDL‑C or available follow‑up data are unlikely to gain information from this observational protocol.

Why it matters

Potential benefit: If successful, this study could show how well inclisiran helps patients in real‑world Spanish practice reach LDL‑cholesterol targets and inform routine prescribing and follow‑up.

How similar studies have performed: Large randomized programs (eg, the ORION trials) have shown marked LDL‑C lowering with inclisiran, but real‑world observational data—especially in Spain—are more limited.

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.

Where this trial is running

Cadiz, Andalusia and 19 other locations

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

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Atherosclerotic Vascular Disease; Heterozygous Familial Hypercholesterolemia; inclisiran; Leqvio®; atherosclerotic vascular disease; heterozygous familial hypercholesterolemia; Spanish clinical practice; Spain