Atherosclerotic Cardiovascular Disease, Primary Hypercholesterolaemia and Mixed Dyslipidaemia
Conditions
Brief 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
Detailed description
Study duration per participant is approximately 12 weeks
Interventions
None listed
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C) | from baseline to week 12 |
| Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ) | week 12 |
| Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C) | from baseline to week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | up to 12 weeks |
| Number of quality defects assessed using product complaints | up to 12 weeks |
Countries
Germany
Outcome results
None listed