Clinical trial NCT05726838: The Belgian REAL (BE.REAL) Registry
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerotic Cardiovascular Disease
Keywords: NIS
atherosclerotic cardiovascular disease
ASCVD
BE.REAL
BE REAL
inclisiran
Belgium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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-May-2023, who provided written informed consent.

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.

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.

* 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.

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.

Primary outcomes:
measure: Mean percent change in LDL-C from baseline
timeFrame: Baseline, up to 39 months
measure: Mean absolute change in LDL-C from baseline
timeFrame: Baseline, up to 39 months
measure: Percentage of patients achieving the guideline-recommended LDL-C target at any time
timeFrame: Up to 39 months
Secondary outcomes:
measure: Percentage of patients maintaining the guideline-recommended LDL-C target
timeFrame: Up to 39 months
measure: Time- adjusted percentage change in LDL-C from baseline
timeFrame: Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39
measure: Change in LDL-C from baseline stratified on background therapy
timeFrame: Baseline, up to 39 months
measure: Percentage of patients remaining on Inclisiran therapy at each injection visit
timeFrame: Up to 39 months
measure: Percentage of patients with dose changes, switching, discontinuation
timeFrame: Up to 39 months
measure: Number of ASCVD-related events
timeFrame: Up to 39 months
measure: Number of possibly related adverse events
timeFrame: Up to 39 months
measure: Number of injection site reactions
timeFrame: Up to 39 months
measure: Number of patients with changes in Lp(a) levels for Inclisiran-treated patients
timeFrame: Up to 39 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Anderlecht
country: Belgium
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Haine-saint-Paul
country: Belgium
facility: Novartis Investigative Site
city: Huy
country: Belgium
facility: Novartis Investigative Site
city: Kortrijk
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Yvoir
country: Belgium
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: