PCSK9 Inhibitors in Hyperlipidemia and Atherosclerosis

NCT07856264 | Not Yet Recruiting

• 1 other identifier: SECEC-2024-034
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hyperlipidemia; Atherosclerotic Cardiovascular Disease (ASCVD)

Outcome Measures

Primary Outcomes (1)

• Change in low-density lipoprotein cholesterol (LDL-C) levels

  Change in low-density lipoprotein cholesterol (LDL-C) levels following treatment with evolocumab or alirocumab in patients with hyperlipidemia and/or atherosclerotic cardiovascular disease (ASCVD) during the study period.

  January-2018 to July-2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age with hyperlipidemia and/or atherosclerotic heart disease in Bogotá.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

MeSH Terms

Conditions

Hyperlipidemias; Atherosclerosis

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09