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AzTrials

Atherosclerotic Vascular DiseaseINSPIRENCT06958315

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

An observational study of Atherosclerotic Vascular Disease and Heterozygous Familial Hypercholesterolemia, run by Novartis Pharmaceuticals at 20 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 99 years
What is being tested?
Inclisiran
How many people
219 participants
Where
20 sitesSpain
Study dates
16 Jun 2025to 1 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Novartis Investigative Site

    Andújar, Jaen, 23740

  • Novartis Investigative Site

    Burgos, 09006

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Fuerteventura, 35600

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Huelva, Andalusia, 21005

  • Novartis Investigative Site

    Jaén, Andalusia, 23007

  • Novartis Investigative Site

    Las Palmas GC, 35010

  • Novartis Investigative Site

    León, 24080

  • Novartis Investigative Site

    Logroño, La Rioja, 26006

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Mallorca, Balearic Islands, 07198

  • Novartis Investigative Site

    Marbella, Andalusia, 29600

  • Novartis Investigative Site

    Puerto Real, Cadiz, 11510

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Seville, 41009

  • Novartis Investigative Site

    Seville, 41013

Other trials in Spain

About this study

Official 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

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

Read the 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.

Being tested
Inclisiran
Keywords
inclisiran, Leqvio®, atherosclerotic vascular disease, heterozygous familial hypercholesterolemia, Spanish clinical practice, Spain, INSPIRE, LDL-C goal attaiment
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InclisiranOther

    Also called KJX839 Leqvio

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

Study groups in NCT06958315
Study groupRoleWhat they receive
InclisiranAdults (≥18 years) with a confirmed clinical indication for inclisiran.
Receives: Other: Inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months following the initiation of inclisiran treatment.

Secondary outcomes (13)

  1. 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.

    Measured: 6 months following the initiation of inclisiran treatment

  2. 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.

    Measured: 6 and 12 months following the initiation of inclisiran treatment

  3. Changes from baseline in LDL-C

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

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

  4. Frequency of AEs

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

    Measured: From inclisiran initiation up to 12 months post-initiation

  5. 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.

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

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

    To evaluate treatment adherence to inclisiran during the study period.

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

  7. Inclisiran reasons for non-persistence

    Number of participants by reasons for non- persistence

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

  8. 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).

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

  9. Changes in Lp(a)

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

    Measured: From inclisiran initiation up to 12 months post-initiation

  10. 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

    Measured: 3 and at 12 months after treatment initiation.

  11. Specialty of the health care profesional prescribing inclisiran

    To describe prescribing specialty.

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

  12. HCP who administers inclisiran

    To describe, HCP that administer inclisiran

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

  13. Site of treatment administration for each dose

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start16 Jun 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958315
Sponsor's protocol ID
CKJX839A1ES03
Acronym
INSPIRE
Status last verified
Aug 2026
First submitted
25 Apr 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerotic Vascular Disease and Heterozygous Familial Hypercholesterolemia, run by Novartis Pharmaceuticals at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C levels - 12 months (time frame: 12 months following the initiation of inclisiran treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06958315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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