The Belgian REAL (BE.REAL) Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Prospective data collection: Patients will be enrolled over a period of 6 months between 01-December-2022 and 31-May-2023 and will have a maximum follow-up of 39 months or 8 injection visits. Retrospective data collection: Retrospective data will also be captured for patients with a first prescription between 01-May-2022 and study start and will be followed up for a maximum of 39 months to assess for study outcomes. In this case, baseline data and data of the first injection visits will be retrieved by the physician and captured in the Clinical Report Form (CRF), followed by prospective data collection during the rest of the follow-up period.

Official Title
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A Belgian Registry to Evaluate the Real Life Treatment With Inclisiran on Top of Standard of Care Lipid-lowering Therapy in Patients With Atherosclerotic Cardiovascular Disease

Conditions
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Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Other: Inclisiran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 18 years or older. 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). Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio. Patients who provide written informed consent to participate in the study. Exclusion Criteria: Patients who have received Inclisiran previously. Patients participating in a clinical trial with investigational product. Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inclisiran<br>Patients prescribed inclisiran on top of standard of care lipid-lowering therapy | Other: Inclisiran<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change in LDL-C from baseline | Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected | 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 | 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 | Up to 39 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | Baseline, up to 39 months | 
| Percentage of patients remaining on Inclisiran therapy at each injection visit | Percentage of patients remaining on Inclisiran therapy at each injection visit will be collected | Up to 39 months | 
| Percentage of patients with dose changes, switching, discontinuation | Percentage of patients with dose changes, switching or discontinuation will be collected | Up to 39 months | 
| Number of ASCVD-related events | Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected | Up to 39 months | 
| Number of possibly related adverse events | Number of possibly related adverse events will be collected | Up to 39 months | 
| Number of injection site reactions | Number of injection site reactions will be collected | Up to 39 months | 
| Number of patients with changes in Lp(a) levels for Inclisiran-treated patients | Number of patients with changes in Lipoprotein (a) levels for Inclisiran-treated patients will be collected | Up to 39 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIS, atherosclerotic cardiovascular disease, ASCVD, BE.REAL, BE REAL, inclisiran, Belgium