Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS)
Study Overview
Primary objectives:
- To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment
- To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector
Secondary objective:
Safety and tolerability
Study details
Study duration per participant is approximately 12 weeks
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
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Conditions:
Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
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Age: 18 Years
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Gender: All
Inclusion Criteria:
- Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease() AND other regular risk factors(*), OR confirmed familial heterozygous hypercholesterolaemia
- Documented maximum dietary and drug lipid-lowering therapy within the last 12 months
- Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy
- The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment
- No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)
- Signed Informed Consent Form
(*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial occlusive disease (PAOD) (**) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular filtration rate (GFR) < 60 ml/min) Exclusion Criteria: - Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study - Existing treatment by lipid apheresis - Age < 18 years - Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC - Current participation in a clinical study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Updated on
06 Mar 2023.
Study ID: NCT05129241