The Belgian REAL (BE.REAL) Registry (BE REAL)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Other: Inclisiran

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Novartis Investigative Site
  • Anderlecht, Belgium, 1070
    • Novartis Investigative Site
  • Brasschaat, Belgium, 2930
    • Novartis Investigative Site
  • Brussels, Belgium, 1020
    • Novartis Investigative Site
  • Edegem, Belgium, 2650
    • Novartis Investigative Site
  • Ghent, Belgium, 9000
    • Novartis Investigative Site
  • Haine-Saint-Paul, Belgium, 7100
    • Novartis Investigative Site
  • Huy, Belgium, 4500
    • Novartis Investigative Site
  • Liège, Belgium, 4000
    • Novartis Investigative Site
  • Mechelen, Belgium, 2800
    • Novartis Investigative Site
  • Antwerpen
    • Turnhout, Antwerpen, Belgium, 2300
      • Novartis Investigative Site
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Novartis Investigative Site
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Novartis Investigative Site
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Novartis Investigative Site
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

It will consist of adult ASCVD patients and elevated levels of LDL-C with an initial prescription for Leqvio between 01-May-2022 and 31- Dec-2025, who provided written informed consent.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inclisiran; Patients prescribed inclisiran on top of standard of care lipid-lowering therapy	Other: Inclisiran; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NIS; atherosclerotic cardiovascular disease; ASCVD; Belgium; inclisiran; BE.REAL; BE REAL
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; ALN-PCS
• Other Study ID Numbers: CKJX839D1BE01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO