Adverse events and inefficacy of PCSK9 Inhibition with evolocumab or alirocumab in hypercholesteraemic patients
Completed
- Conditions
- hypercholesterolemiahigh cholesterol10013317
- Registration Number
- NL-OMON55799
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 71
Inclusion Criteria
Patients
- On therapy or discontinued therapy with alirocumab 75mg 1x/2weeks or 150mg
1x/2weeks, or with evolocumab 140mg 1x/2weeks.
- Failure of PCSK9 inhibitor therapy, due to adverse effects leading to
discontinuation of the drug
OR
- Failure of PCSK9 inhibitor therapy, due to less than 30 percent reduction in
LDL-C observed by the referring physician
- >18 years of age, Controls:
- On therapy with alirocumab or with evolocumab
- On therapy with alirocumab or with evolocumab
- No adverse effects leading to discontinuation of the drug
- LDL-C reduction above 30 percent., - >18 years of age.
Exclusion Criteria
None
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are differences in clinical parameters (e.g., patient<br /><br>anthropometrics between patients and controls, mutations in the PCSK9 gene<br /><br>possibly interfering with PCSK9 inhibitor therapy, variants in other lipid<br /><br>metabolism or PCSK9 related genes, gene expression, (semi)quantification of<br /><br>proteins (PCSK9 protein, other proteins involved in lipid metabolism,<br /><br>proteomics), (semi-)quantification of metabolites (e.g. lipids/fatty acids).</p><br>
- Secondary Outcome Measures
Name Time Method <p>nvt</p><br>