The Belgian REAL (BE.REAL) Registry

N/AActive Not RecruitingNCT05726838

Novartis Pharmaceuticals600 enrolled

Overview

This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected. The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions.

The study aims to assess the effectiveness, safety and adherence for Inclisiran in combination with lipid-lowering therapy (LLT) under conditions of routine clinical practice. The Inclisiran cohort will include patients receiving Inclisiran therapy as per the approved label independently of background Standard of Care (SoC) therapy. This study will include both primary data collection and secondary use of data.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

InclisiranOTHER

There is no treatment allocation. Patients administered inclisiran by prescription will be enrolled. The patients will receive inclisiran therapy as per the approved label and Belgian reimbursement conditions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who are 18 years or older. 2. Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible for commercially available Leqvio, as defined by the reimbursement criteria: Patients with ASCVD documented by previous coronary heart disease (CHD), cerebrovascular disease or peripheral artery disease (PAD) and LDL-C ≥ 100mg/dL despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication). 3. Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio. 4. Patients who provide written informed consent to participate in the study. Exclusion Criteria: 1. Patients who have received Inclisiran previously. 2. Patients participating in a clinical trial with investigational product. 3. Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.

Outcomes

Primary Outcomes

Mean percent change in LDL-C from baseline

Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected

Time frame: Baseline, up to 39 months

Mean absolute change in LDL-C from baseline

Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline

Time frame: Baseline, up to 39 months

Percentage of patients achieving the guideline-recommended LDL-C target at any time

Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected

Time frame: Up to 39 months

Secondary Outcomes

Percentage of patients maintaining the guideline-recommended LDL-C target

Percentage of patients maintaining the guideline-recommended LDL-C target (once achieved) for the duration of the study will be collected

Time frame: Up to 39 months

Time- adjusted percentage change in LDL-C from baseline

time- adjusted percentage change in LDL-C from baseline to 3 months (2nd injection), 9 months (3rd injection), 15 months (4th injection), 21 months (5th injection), 27 months (6th injection), 33 months (7th injection) and 39 months (8th injection)

Time frame: Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39

Change in LDL-C from baseline stratified on background therapy

Change in LDL-C from baseline stratified on background therapy will be collected

Time frame: Baseline, up to 39 months

Percentage of patients remaining on Inclisiran therapy at each injection visit

Data from ClinicalTrials.gov

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