A Randomized, Placebo-Controlled Mechanistic Clinical Trial of PCSK9 Inhibition With Evolocumab in Patients Undergoing Open Abdominal Aortic Aneurysm Repair
University of Pennsylvania
Summary
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.
Description
After being informed about the study and its potential risks, all patients giving informed consent will undergo a baseline visit and be randomized to received either evolocumab 140mg subcutaneously or placebo. This baseline visit includes a vital signs assessment, laboratory tests, medical history and medication review, a pregnancy test (if applicable), and training on how to perform drug injections. Participants will receive 3 doses/autoinjectors of study drug or placebo and be instructed to perform injections every 14 days starting 5 weeks prior to their scheduled AAA repair. If the baseline…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Abdominal aortic aneurysm (AAA) requiring open surgical repair 2. Age \> 18 3. Provision of signed and dated informed consent form 4. Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: 1. Prior use of a PCSK9 inhibitor (evolocumab, alirocumab, inclisiran) within 6 months of the baseline visit 2. LDL-C \< 40 mg/dL (within 3 months of baseline visit) 3. Known allergy to PCSK9 inhibitor 4. Aortic dissection 5. Vascular connective tissue disorders 6. Type I-III or V Thoraco-abdominal Aortic Aneurysm 7.…
Interventions
- DrugEvolocumab
See arm description.
- DrugPlacebo
See arm description.
Location
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania