Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

• Status: Not yet recruiting
• Trial end date: 2028-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Amgen; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Evolocumab

Criteria

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. Vasculitis or inflammatory aneurysm

8. Pregnant or lactating women

9. Poorly controlled diabetes (A1C > 10%)

10. Chronic kidney disease Stage 4/5 or End Stage Renal Disease (ESRD) on hemodialysis (HD)

11. Liver Disease (alanine transaminase [ALT] or aspartate aminotransferase [ALT] > 3.0 x upper limits of normal) (within 3 months of baseline visit)

12. Known latex or naturally rubber allergy

13. 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.

14. Any other condition that the Investigator feels prohibits participants' ability to comply with study or follow up.