NCT05726838

The Belgian REAL (BE.REAL) Registry

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-15
• Primary completion: 2029-03-30
• Completion: 2029-03-30
• First posted: 2023-02-14
• Last updated: 2026-03-12

Locations

15 sites across 1 country: Belgium