Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

Launched by UNIVERSITY OF PENNSYLVANIA · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called evolocumab, which lowers "bad" cholesterol (known as LDL-C), may affect patients with abdominal aortic aneurysm (AAA). AAA is a condition where the large artery in the belly becomes enlarged, and the researchers want to see if reducing cholesterol levels can help improve the health of the blood vessel's tissue and cells. Participants will receive either evolocumab injections or a placebo (an inactive substance) to compare how their aorta is affected by the treatment.

To be eligible for this trial, participants must be over 18 years old and have an AAA that needs surgical repair. They must also be willing to follow the study procedures and sign a consent form. However, certain people cannot participate, such as those who have used similar medications recently, have very low cholesterol levels, or have specific health conditions like severe diabetes or kidney disease. While the trial is not yet recruiting, those who take part can expect to receive careful monitoring throughout the study to see how the treatment affects their condition.

Gender

ALL

Eligibility 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.