Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
ConditionAbdominal Aortic Aneurysm
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.
Eligibility criteria
Qualifiers
Abdominal aortic aneurysm (AAA) requiring open surgical repair
Age > 18
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Disqualifiers
Prior use of a PCSK9 inhibitor (evolocumab, alirocumab, inclisiran) within 6 months of the baseline visit
LDL-C < 40 mg/dL (within 3 months of baseline visit)
Known allergy to PCSK9 inhibitor
Aortic dissection
Trial design
Treatments tested in this trial
- Evolocumab
- Placebo
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Amgen
Collaborator
Source ClinicalTrials.gov