HyperlipidemiaNCT07856264
PCSK9 Inhibitors in Hyperlipidemia and Atherosclerosis
An observational study of Hyperlipidemia and Atherosclerotic Cardiovascular Disease (ASCVD), run by Fundación Santa Fe de Bogota.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia, Atherosclerotic Cardiovascular Disease (ASCVD)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age with hyperlipidemia and/or atherosclerotic heart disease in Bogotá.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Real-World Experience With the Use of PCSK9 Inhibitors in Patients With Hyperlipidemia and Atherosclerotic Cardiovascular Disease at a University Hospital in Bogotá, Colombia
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.
- Medical subject headings
- Hyperlipidemias, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January-2018 to July-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856264
- Sponsor's protocol ID
- SECEC-2024-034
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Experience With the Use of PCSK9 Inhibitors in Patients With Hyperlipidemia and Atherosclerotic Cardiovascular Disease at a University Hospital in Bogotá, Colombia
- ClinicalTrials.gov ID
- NCT07856264
- Acronym / sponsor ID
- SECEC-2024-034
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age with hyperlipidemia and/or atherosclerotic heart disease in Bogotá.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in low-density lipoprotein cholesterol (LDL-C) levels
Time frame: January-2018 to July-2024
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia and Atherosclerotic Cardiovascular Disease (ASCVD), run by Fundación Santa Fe de Bogota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in low-density lipoprotein cholesterol (LDL-C) levels (time frame: January-2018 to July-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.