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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heterozygous Familial Hypercholesterolemia; Atherosclerotic Vascular Disease
• Intervention / Treatment: Other: Inclisiran

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 lipoprotein-cholesterol (LDL-C) goals according to their cardiovascular risk at 12 months after the initiation of inclisiran treatment.

The study also aims to evaluate changes in LDL-C levels, safety profile, adherence and persistence to inclisiran treatment, use of concomitant lipid-lowering therapy (LLT), and patient satisfaction with inclisiran among other variables collected in clinical practice.

This is a non-interventional, prospective, multicentric, and nationwide study that will be conducted in routine clinical practice in Spain. This study will consist of three visits, coinciding with those conducted as part of the patients' routine follow-up, without interfering with the clinical practice of the participating centers. A blood test to assess LDL-C levels will be conducted at 3, 6, 9 and 12 months after inclisiran initiation, according to clinical practice.

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• Spain
  • Burgos, Spain, 09006
    • Novartis Investigative Site
  • Córdoba, Spain, 14004
    • Novartis Investigative Site
  • Fuerteventura, Spain, 35600
    • Novartis Investigative Site
  • Las Palmas GC, Spain, 35010
    • Novartis Investigative Site
  • Málaga, Spain, 29010
    • Novartis Investigative Site
  • Salamanca, Spain, 37007
    • Novartis Investigative Site
  • Seville, Spain, 41009
    • Novartis Investigative Site
  • Seville, Spain, 41013
    • Novartis Investigative Site
  • Andalusia
    • Cadiz, Andalusia, Spain, 11009
      • Novartis Investigative Site
    • Granada, Andalusia, Spain, 18014
      • Novartis Investigative Site
    • Huelva, Andalusia, Spain, 21005
      • Novartis Investigative Site
    • Jaén, Andalusia, Spain, 23007
      • Novartis Investigative Site
    • Marbella, Andalusia, Spain, 29600
      • Novartis Investigative Site
  • Balearic Islands
    • Mallorca, Balearic Islands, Spain, 07198
      • Novartis Investigative Site
  • Cadiz
    • Puerto Real, Cadiz, Spain, 11510
      • Novartis Investigative Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Novartis Investigative Site
  • Jaen
    • Andújar, Jaen, Spain, 23740
      • Novartis Investigative Site
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Novartis Investigative Site
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) with a confirmed clinical indication for inclisiran.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inclisiran; Adults (≥18 years) with a confirmed clinical indication for inclisiran.	Other: Inclisiran; This is an observational study, there is no treatment allocation.; Other Names: KJX839 Leqvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C levels - 12 months	Proportion of participants reaching guideline-established low densitiy lipoprotein-Cholesterol (LDL-C) targets according to their Cardiovascular (CV) risk; LDL-C <55 mg/dL for ASCVD participants.; LDL-C <70 mg/dL for HeHF patients.	12 months following the initiation of inclisiran treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C levels - 6 months	Proportion of participants reaching guideline-established LDL-C targets according to their CV risk; LDL-C <55 mg/dL for ASCVD participants.; LDL-C <70 mg/dL for HeHF patients.	6 months following the initiation of inclisiran treatment
non-HLDL-C levels	Proportion of participants with hypertriglyceridemia (triglycerides >400 mg/dL) reaching guideline-established non-HDL-C targets according to their CV risk; Non-HDL-C <85 mg/dL for ASCVD patients.; Non-HDL-C <100 mg/dL for HeHF patients.	6 and 12 months following the initiation of inclisiran treatment
Changes from baseline in LDL-C	Change from baseline to mean LDL-C in PCSK9i naïve patients and patients pre-treated with PCSK9i, separately.	Baseline, 3, 6, 9 and 12 months following the initiation of inclisiran treatment
Frequency of AEs	Incidence of AEs including, number of cardiovascular events, revascularizations, emergency visits, and hospitalizations qualifying and reported as AEs.	From inclisiran initiation up to 12 months post-initiation
Adherence rate to the concomitant LLT treatment	Number of participants with a Morisky Medication Adjerence Slace (MMAS) of over 80%To describe the utilization and adherence to concomitant LLT during inclisiran treatment.	From 1st visit up to 12 months after inclisiran initiation
Inclisiran reasons for non-persistence	Number of participants by reasons for non- persistence	From 1st visit up to 12 months after inclisiran initiation
Lp(a)	Proportion of participants with Lp(a) ≥50 mg/dL (≥125 nmol/L), ≥70 mg/dL (≥175 nmol/L), ≥90 mg/dL (≥225 nmol/L).	When available, from baseline up to 12 months after inclisiran initiation
Changes in Lp(a)	To describe changes in Lp(a) at any time after inclisiran treatment, only in patients tested by clinical judgment.	From inclisiran initiation up to 12 months post-initiation
Patient satisfaction with inclisiran, score on TSQM-II	Treatment Satisfaction Questionnaire for Medication II evaluates satisfaction with treatment effectiveness, side effects, convenience, and global satisfaction. The TSQM-II consists of 11 items, each with 7 response options. Scores for each domain are calculated by averaging responses, transformed to a 0-100 scale, where higher scores indicate greater satisfaction	3 and at 12 months after treatment initiation.
HCP who administers inclisiran	To describe, HCP that administer inclisiran	From 1st visit up to 12 months after inclisiran initiation
Site of treatment administration for each dose	To describe site of treatment administration (primary, secondary or tertiary hospital, primary care center)	From 1st visit up to 12 months after inclisiran initiation
Proportion of participants adhering to the prescribed inclisiran dosing schedule	To evaluate treatment adherence to inclisiran during the study period.	From 1st visit up to 12 months after inclisiran initiation
Specialty of the health care profesional prescribing inclisiran	To describe prescribing specialty.	From 1st visit up to 12 months after inclisiran initiation

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: heterozygous familial hypercholesterolemia; Spain; inclisiran; INSPIRE; atherosclerotic vascular disease; Leqvio®; Spanish clinical practice; LDL-C goal attaiment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; ALN-PCS
• Other Study ID Numbers: CKJX839A1ES03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No