The Belgian REAL (BE.REAL) Registry

Recruiting

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Other: Inclisiran

• Registration Number: NCT05726838
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-04-15
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inclisiran	Inclisiran	Patients prescribed inclisiran on top of standard of care lipid-lowering therapy

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving the guideline-recommended LDL-C target at any time	Up to 39 months	Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected
Mean percent change in LDL-C from baseline	Baseline, up to 39 months	Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected
Mean absolute change in LDL-C from baseline	Baseline, up to 39 months	Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline

Secondary Outcome Measures

Name	Time	Method
Number of injection site reactions	Up to 39 months	Number of injection site reactions will be collected
Change in LDL-C from baseline stratified on background therapy	Baseline, up to 39 months	Change in LDL-C from baseline stratified on background therapy will be collected
Number of possibly related adverse events	Up to 39 months	Number of possibly related adverse events will be collected
Percentage of patients remaining on Inclisiran therapy at each injection visit	Up to 39 months	Percentage of patients remaining on Inclisiran therapy at each injection visit will be collected
Percentage of patients with dose changes, switching, discontinuation	Up to 39 months	Percentage of patients with dose changes, switching or discontinuation will be collected
Number of patients with changes in Lp(a) levels for Inclisiran-treated patients	Up to 39 months	Number of patients with changes in Lipoprotein (a) levels for Inclisiran-treated patients will be collected
Percentage of patients maintaining the guideline-recommended LDL-C target	Up to 39 months	Percentage of patients maintaining the guideline-recommended LDL-C target (once achieved) for the duration of the study will be collected
Time- adjusted percentage change in LDL-C from baseline	Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39	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)
Number of ASCVD-related events	Up to 39 months	Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇪 Yvoir, Belgium