Last Update: Dec 12, 2025
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
ClinicalTrials.gov Identifier:
NCT05726838
Novartis Reference Number:CKJX839D1BE01
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Atherosclerotic Cardiovascular Disease
Recruiting
600
Apr 15, 2022
Mar 31, 2029
All
18 Years - 99 Years (Adult, Older Adult)

Interventions

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.

Eligibility Criteria

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.

Novartis Investigative Site

Recruiting

Aalst,9300,Belgium

Novartis Investigative Site

Recruiting

Anderlecht,1070,Belgium

Novartis Investigative Site

Recruiting

Brasschaat,2930,Belgium

Novartis Investigative Site

Recruiting

Edegem,2650,Belgium

Novartis Investigative Site

Recruiting

Genk,3600,Belgium

Novartis Investigative Site

Recruiting

Huy,4500,Belgium

Novartis Investigative Site

Recruiting

Leuven,3000,Belgium

Novartis Investigative Site

Recruiting

Mechelen,2800,Belgium

Novartis Investigative Site

Recruiting

Brussels,1020,Belgium

Novartis Investigative Site

Recruiting

Ghent,9000,Belgium

Novartis Investigative Site

Recruiting

Haine-Saint-Paul,7100,Belgium

Novartis Investigative Site

Recruiting

Liège,4000,Belgium

Novartis Investigative Site

Recruiting

Turnhout,Antwerpen,2300,Belgium

Novartis Investigative Site

Recruiting

Yvoir,Namur,5530,Belgium

Novartis Investigative Site

Recruiting

Kortrijk,West-Vlaanderen,8500,Belgium

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111