Active — Not RecruitingNot Applicable

The Belgian REAL (BE.REAL) Registry

Belgium600 participantsStarted 2022-04-15

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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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:
✓. 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.

What they're measuring

Mean percent change in LDL-C from baseline

Timeframe: Baseline, up to 39 months

Mean absolute change in LDL-C from baseline

Timeframe: Baseline, up to 39 months

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

Timeframe: Up to 39 months

Trial details

NCT IDNCT05726838

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-03-30

View on ClinicalTrials.gov More Atherosclerotic Cardiovascular Disease trials