Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 assessment occurs 5 weeks prior to their scheduled AAA, the first injection will be performed during this visit. Participants will have the option of coming back to the site for injections 2 and 3 or perform these injections at home under telehealth supervision. At the time of open AAA repair, participants will repeat laboratory tests and have a sample of aneurysm tissue taken. Participants will then have a follow up phone call 4 weeks after AAA repair to assess for any adverse events. At the conclusion of the study investigators will examine gene expression and protein levels in the aortic tissue to determine the impact of LDL-C lowering with evolocumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06081153
Study type	Interventional
Source	University of Pennsylvania
Contact	Kevin Dougherty, MPH
Phone	215-662-2243
Email	kevin.dougherty@pennmedicine.upenn.edu
Status	Not yet recruiting
Phase	Early Phase 1
Start date	July 1, 2024
Completion date	November 1, 2028

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04227054` - Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks	N/A
Active, not recruiting	`NCT03687489` - Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System	N/A
Active, not recruiting	`NCT03507413` - Metformin Therapy in Non-diabetic AAA Patients	Phase 2/Phase 3
Not yet recruiting	`NCT05756283` - The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair	N/A
Not yet recruiting	`NCT04089241` - Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair	N/A
Active, not recruiting	`NCT02604303` - A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Completed	`NCT02229006` - Sodium Fluoride Imaging of Abdominal Aortic Aneurysms	N/A
Completed	`NCT02224794` - LIFE Study: Least Invasive Fast-Track EVAR
Terminated	`NCT01843335` - Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair	N/A
Terminated	`NCT02469376` - Evaluation of a New Imagingtechnologie for Thrombosis	Phase 1
Completed	`NCT01118520` - AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)	Phase 2
Terminated	`NCT01425242` - Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension	N/A
Completed	`NCT00746122` - Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair	N/A
Completed	`NCT03952780` - Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Completed	`NCT00583414` - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients	N/A
Recruiting	`NCT05864560` - Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Completed	`NCT01683084` - Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms	Phase 4
Active, not recruiting	`NCT03180996` - Global Fenestrated Anaconda Clinical sTudy
Completed	`NCT02493296` - The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Completed	`NCT03320408` - Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers