The Belgian REAL (BE.REAL) Registry

Last updated: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Hypercholesterolemia

Vascular Diseases

Treatment

Inclisiran

Clinical Study ID

NCT05726838
CKJX839D1BE01
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who are 18 years or older.

  2. Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible forcommercially 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/dLdespite a treatment of min 6 weeks with max tolerated statin (unless intolerance orcontra-indication) in combination with ezetimibe (unless intolerance orcontra-indication).

  3. Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD whoare eligible for commercially available Leqvio.

  4. Patients who provide written informed consent to participate in the study.

Exclusion

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 establishedAtherosclerotic Cardiovascular Disease.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Inclisiran
Phase:
Study Start date:
April 15, 2022
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Aalst, 9300
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Brasschaat, 2930
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Bruxelles, 1020
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Genk, 3600
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Gent, 9000
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Haine-saint-Paul, 7100
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Huy, 4500
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Liege, 4000
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Turnhout, 2300
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Yvoir, 5530
    Belgium

    Active - Recruiting

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