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NCT Number: NCT06958315

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atherosclerotic Vascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heterozygous Familial Hypercholesterolemia Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Cadiz, Andalusia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

Inclisiran

Other

This is an observational study, there is no treatment allocation.

Other names: KJX839 Leqvio

Primary outcomes

  1. LDL-C levels - 12 months

    Time frame: 12 months following the initiation of inclisiran treatment.

    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.

Secondary outcomes

  1. LDL-C levels - 6 months

    Time frame: 6 months following the initiation of inclisiran treatment

    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.

  2. non-HLDL-C levels

    Time frame: 6 and 12 months following the initiation of inclisiran treatment

    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.

  3. Changes from baseline in LDL-C

    Time frame: Baseline, 3, 6, 9 and 12 months following the initiation of inclisiran treatment

    Change from baseline to mean LDL-C in PCSK9i naïve patients and patients pre-treated with PCSK9i, separately.

  4. Frequency of AEs

    Time frame: From inclisiran initiation up to 12 months post-initiation

    Incidence of AEs including, number of cardiovascular events, revascularizations, emergency visits, and hospitalizations qualifying and reported as AEs.

  5. Adherence rate to the concomitant LLT treatment

    Time frame: From 1st visit up to 12 months after inclisiran initiation

    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.

  6. Proportion of participants adhering to the prescribed inclisiran dosing schedule

    Time frame: From 1st visit up to 12 months after inclisiran initiation

    To evaluate treatment adherence to inclisiran during the study period.

  7. Inclisiran reasons for non-persistence

    Time frame: From 1st visit up to 12 months after inclisiran initiation

    Number of participants by reasons for non- persistence

  8. Lp(a)

    Time frame: When available, from baseline up to 12 months after inclisiran initiation

    Proportion of participants with Lp(a) ≥50 mg/dL (≥125 nmol/L), ≥70 mg/dL (≥175 nmol/L), ≥90 mg/dL (≥225 nmol/L).

  9. Changes in Lp(a)

    Time frame: From inclisiran initiation up to 12 months post-initiation

    To describe changes in Lp(a) at any time after inclisiran treatment, only in patients tested by clinical judgment.

  10. Patient satisfaction with inclisiran, score on TSQM-II

    Time frame: 3 and at 12 months after treatment initiation.

    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

  11. Specialty of the health care profesional prescribing inclisiran

    Time frame: From 1st visit up to 12 months after inclisiran initiation

    To describe prescribing specialty.

  12. HCP who administers inclisiran

    Time frame: From 1st visit up to 12 months after inclisiran initiation

    To describe, HCP that administer inclisiran

  13. Site of treatment administration for each dose

    Time frame: From 1st visit up to 12 months after inclisiran initiation

    To describe site of treatment administration (primary, secondary or tertiary hospital, primary care center)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: INSPIRE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 6, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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