The Belgian REAL (BE.REAL) Registry

Atherosclerotic Cardiovascular Disease Clinical Trial

— BE REAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726838
• Other study ID #: CKJX839D1BE01
• Status: Recruiting
• Start date: May 27, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Anderlecht
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Haine-saint-Paul
Belgium	Novartis Investigative Site	Huy
Belgium	Novartis Investigative Site	Kortrijk
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Turnhout
Belgium	Novartis Investigative Site	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients with dose changes, switching, discontinuation	Percentage of patients with dose changes, switching or discontinuation will be collected	Up to 39 months
Secondary	Number of ASCVD-related events	Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected	Up to 39 months
Secondary	Number of possibly related adverse events	Number of possibly related adverse events will be collected	Up to 39 months
Secondary	Number of injection site reactions	Number of injection site reactions will be collected	Up to 39 months
Secondary	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