The Belgian REAL (BE.REAL) Registry

Launched by NOVARTIS PHARMACEUTICALS · Feb 3, 2023

Keywords

ClinConnect Summary

The Belgian REAL (BE.REAL) Registry is a clinical study aimed at understanding how well Inclisiran works in patients with Atherosclerotic Cardiovascular Disease (ASCVD). This condition involves the buildup of fatty deposits in the arteries, which can lead to serious health issues like heart attacks and strokes. The study is observational, meaning that researchers will collect information about patients' health during their regular doctor visits without changing their treatment plans. Interested participants will receive Inclisiran therapy along with their usual medications, as long as they meet specific criteria.

To join the study, participants need to be at least 18 years old and have ASCVD documented by previous heart or blood vessel problems. They should also have high cholesterol levels despite being on the maximum tolerated dose of statin medication for at least six weeks. Participants will need to provide written consent and cannot have taken Inclisiran before or be involved in another clinical trial at the same time. This study is currently recruiting patients, so if you or a family member fit the criteria, it might be an opportunity to help advance understanding of this treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who are 18 years or older.
• 2. 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).
• • 3. Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio.
• • 4. Patients who provide written informed consent to participate in the study.
• 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 established Atherosclerotic Cardiovascular Disease.