Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS) (MARS)

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Sanofi
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Updated on 19 September 2022
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Summary

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

Description

Study duration per participant is approximately 12 weeks

Details
Condition Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
Age 18years or above
Clinical Study IdentifierNCT05129241
SponsorSanofi
Last Modified on19 September 2022

Eligibility

 Yes No Not Sure

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

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
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