Last Update: Oct 25, 2023
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:
Novartis Reference Number:CKJX839D1BE01
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.

- 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.

Atherosclerotic Cardiovascular Disease
Recruiting
300
May 27, 2022
Jul 01, 2026
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.

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