Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06081153
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-10-03
Brief Title:
Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Randomized Placebo-Controlled Mechanistic Clinical Trial of PCSK9 Inhibition With Evolocumab in Patients Undergoing Open Abdominal Aortic Aneurysm Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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 dosesautoinjectors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL166991 | NIH | None | httpsreporternihgovquickSearchR01HL166991 |