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
1 other identifier
observational
600
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2022
CompletedFirst Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2029
March 12, 2026
March 1, 2026
7 years
February 3, 2023
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (9)
Percentage of patients maintaining the guideline-recommended LDL-C target
Up to 39 months
Time- adjusted percentage change in LDL-C from baseline
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
Baseline, up to 39 months
Percentage of patients remaining on Inclisiran therapy at each injection visit
Up to 39 months
Percentage of patients with dose changes, switching, discontinuation
Up to 39 months
- +4 more secondary outcomes
Study Arms (1)
Inclisiran
Patients prescribed inclisiran on top of standard of care lipid-lowering therapy
Interventions
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 Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients who have received Inclisiran previously.
- Patients participating in a clinical trial with investigational product.
- Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novartis Investigative Site
Turnhout, Antwerpen, 2300, Belgium
Novartis Investigative Site
Genk, Limburg, 3600, Belgium
Novartis Investigative Site
Yvoir, Namur, 5530, Belgium
Novartis Investigative Site
Leuven, Vlaams Brabant, 3000, Belgium
Novartis Investigative Site
Kortrijk, West-Vlaanderen, 8500, Belgium
Novartis Investigative Site
Aalst, 9300, Belgium
Novartis Investigative Site
Anderlecht, 1070, Belgium
Novartis Investigative Site
Brasschaat, 2930, Belgium
Novartis Investigative Site
Brussels, 1020, Belgium
Novartis Investigative Site
Edegem, 2650, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Haine-Saint-Paul, 7100, Belgium
Novartis Investigative Site
Huy, 4500, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Mechelen, 2800, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 14, 2023
Study Start
April 15, 2022
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
March 30, 2029
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share