The Belgian REAL (BE.REAL) Registry

Last updated: May 29, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not 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: 600
Treatment Group(s): 1
Primary Treatment: Inclisiran
Phase:
Study Start date:
April 15, 2022
Estimated Completion Date:
March 30, 2029

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.