Status:
NOT_YET_RECRUITING
Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Amgen
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Vascular connective tissue disorders
- Type I-III or V Thoraco-abdominal Aortic Aneurysm
- Vasculitis or inflammatory aneurysm
- Pregnant or lactating women
- Poorly controlled diabetes (A1C \> 10%)
- Chronic kidney disease Stage 4/5 or End Stage Renal Disease (ESRD) on hemodialysis (HD)
- Liver Disease (alanine transaminase \[ALT\] or aspartate aminotransferase \[ALT\] \> 3.0 x upper limits of normal) (within 3 months of baseline visit)
- Known latex or naturally rubber allergy
- Treatment with another investigational product within 30 days or 5 half-lives of the investigation drug before consent (whichever is longer) that would have an impact on endpoints associated with this trial.
- Any other condition that the Investigator feels prohibits participants' ability to comply with study or follow up.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06081153
Start Date
July 1 2026
End Date
February 28 2028
Last Update
January 8 2026
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