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:

  • Conditions:
    Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
  • Age: 18 Years
  • 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