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

Novartis Pharmaceuticals200 enrolled

Overview

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

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

200

Conditions

Atherosclerotic Vascular Disease Heterozygous Familial Hypercholesterolemia

Interventions

InclisiranOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (16)

Novartis Investigative Site

Cadiz, Andalusia, Spain

RECRUITING

Novartis Investigative Site

Granada, Andalusia, Spain

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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