Hypercholesterolemia, Familial Clinical Trial
Official title:
Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®
NCT number | NCT04313270 |
Other study ID # | 2015/261 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2017 |
Est. completion date | December 1, 2025 |
Verified date | March 2021 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Protein convertase subtilisin kexin type 9 (PCSK-9) inhibitors demonstrated efficacy in cholesterol reduction and in the prevention of cardiovascular events. The investigators will evaluate changes in lipid profile, oxidation markers and subclinical atherosclerosis in patients with familial hypercholesterolemia (FH) during 12 weeks of treatment with a PCSK-9 inhibitor, Evolocumab®.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosis of FH (clinical and/or genetic) - eligibility of patients to start a treatment with PCSK-9 according to 2016 ESC guidelines. Exclusion Criteria: - age < 18 years - inability to understand or sign the informed consent - high level of transaminases ( >3x upper normal limit) - hypertriglyceridemia ( >150 mg/dl) - end-stage renal disease (filtration rate < 30 ml/min/mq) - current malignant disease or a diagnosis of malignancy in the 2 years prior to the first visit - previous exposure to PCSK-9 inhibitors - presence of hypercholesterolemia secondary to other causes (hypothyroidism, hormone therapies, corticosteroids etc.) |
Country | Name | City | State |
---|---|---|---|
Italy | Matteo Di Minno | Napoli |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subclinical atherosclerosis | evaluation of subclinical atherosclerosis in patients receiving Evolocumab | 12 weeks |
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