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NCT07856264
PCSK9 Inhibitors in Hyperlipidemia and Atherosclerosis
Conditions: Hyperlipidemia, Atherosclerotic Cardiovascular Disease (ASCVD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Fundación Santa Fe de Bogota
Summary
PCSK9 inhibitors, including evolocumab and alirocumab, are lipid-lowering therapies used in patients with hyperlipidemia and atherosclerotic cardiovascular disease. This retrospective observational study aims to describe changes in low-density lipoprotein cholesterol (LDL-C) levels following the use of PCSK9 inhibitors in adult patients with hyperlipidemia and/or atherosclerotic cardiovascular disease treated at Fundación Santa Fe de Bogotá between 2018 and 2024. The study will also describe patients' clinical characteristics, treatment effectiveness, safety, adherence, and barriers to treatment access. Data will be obtained from medical records, cardiology records, and telephone interviews when needed to complete missing information.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 18 years or older with a clinical diagnosis of hyperlipidemia and/or atherosclerotic cardiovascular disease (ASCVD) according to ESC/EAS guidelines who also meet the following criteria:
Patients who initiated treatment with evolocumab or alirocumab between 2018 and 2024.
Patients who received at least one dose of evolocumab or alirocumab. Patients followed by the Cardiology Department at Fundación Santa Fe de Bogotá. Patients with at least one measured and/or calculated low-density lipoprotein cholesterol (LDL-C) level within the 6 months prior to initiation of evolocumab or alirocumab.
Exclusion Criteria:
* Patients with prior exposure to PCSK9 inhibitor therapy within the 6 months before initiation of evolocumab or alirocumab.
Patients without at least one LDL-C measurement after initiation of PCSK9 inhibitor therapy.
Patients without at least one LDL-C measurement within the 6 months prior to initiation of evolocumab or alirocumab.
Patients with incomplete medical records from which identification or contact information cannot be obtained.
Source: ClinicalTrials.gov (NCT07856264). StuddyBuddy aggregates publicly available trial information.