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

NCT ID: NCT06958315

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-16

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Atherosclerotic Vascular Disease Heterozygous Familial Hypercholesterolemia

Keywords

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inclisiran Leqvio® atherosclerotic vascular disease heterozygous familial hypercholesterolemia Spanish clinical practice Spain INSPIRE LDL-C goal attaiment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inclisiran

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

Inclisiran

Intervention Type OTHER

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

Interventions

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Inclisiran

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

Intervention Type OTHER

Other Intervention Names

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KJX839 Leqvio

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Cadiz, Andalusia, Spain

Site Status RECRUITING

Novartis Investigative Site

Granada, Andalusia, Spain

Site Status RECRUITING

Novartis Investigative Site

Huelva, Andalusia, Spain

Site Status RECRUITING

Novartis Investigative Site

Jaén, Andalusia, Spain

Site Status RECRUITING

Novartis Investigative Site

Marbella, Andalusia, Spain

Site Status RECRUITING

Novartis Investigative Site

Puerto Real, Cadiz, Spain

Site Status RECRUITING

Novartis Investigative Site

Logroño, La Rioja, Spain

Site Status RECRUITING

Novartis Investigative Site

Burgos, , Spain

Site Status RECRUITING

Novartis Investigative Site

Córdoba, , Spain

Site Status RECRUITING

Novartis Investigative Site

Fuerteventura, , Spain

Site Status RECRUITING

Novartis Investigative Site

Las Palmas GC, , Spain

Site Status RECRUITING

Novartis Investigative Site

León, , Spain

Site Status RECRUITING

Novartis Investigative Site

Málaga, , Spain

Site Status RECRUITING

Novartis Investigative Site

Salamanca, , Spain

Site Status RECRUITING

Novartis Investigative Site

Seville, , Spain

Site Status RECRUITING

Novartis Investigative Site

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CKJX839A1ES03

Identifier Type: -

Identifier Source: org_study_id