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Active, Not Recruiting

NCT Number: NCT05726838

The Belgian REAL (BE.REAL) Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are 18 years or older.
  • 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).

  • Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio.
  • Patients who provide written informed consent to participate in the study.

Exclusion criteria

  • Patients who have received Inclisiran previously.
  • Patients participating in a clinical trial with investigational product.
  • Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.

Treatment and study plan

Inclisiran

Other

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.

Primary outcomes

  1. Mean percent change in LDL-C from baseline

    Time frame: Baseline, up to 39 months

    Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected

  2. Mean absolute change in LDL-C from baseline

    Time frame: Baseline, up to 39 months

    Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline

  3. Percentage of patients achieving the guideline-recommended LDL-C target at any time

    Time frame: Up to 39 months

    Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected

Secondary outcomes

  1. Percentage of patients maintaining the guideline-recommended LDL-C target

    Time frame: Up to 39 months

    Percentage of patients maintaining the guideline-recommended LDL-C target (once achieved) for the duration of the study will be collected

  2. Time- adjusted percentage change in LDL-C from baseline

    Time frame: Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39

    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)

  3. Change in LDL-C from baseline stratified on background therapy

    Time frame: Baseline, up to 39 months

    Change in LDL-C from baseline stratified on background therapy will be collected

  4. Percentage of patients remaining on Inclisiran therapy at each injection visit

    Time frame: Up to 39 months

    Percentage of patients remaining on Inclisiran therapy at each injection visit will be collected

  5. Percentage of patients with dose changes, switching, discontinuation

    Time frame: Up to 39 months

    Percentage of patients with dose changes, switching or discontinuation will be collected

  6. Number of ASCVD-related events

    Time frame: Up to 39 months

    Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected

  7. Number of possibly related adverse events

    Time frame: Up to 39 months

    Number of possibly related adverse events will be collected

  8. Number of injection site reactions

    Time frame: Up to 39 months

    Number of injection site reactions will be collected

  9. Number of patients with changes in Lp(a) levels for Inclisiran-treated patients

    Time frame: Up to 39 months

    Number of patients with changes in Lipoprotein (a) levels for Inclisiran-treated patients will be collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: BE REAL

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Feb 14, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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