Evolocumab for Abdominal Aortic Aneurysm
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore whether the drug evolocumab can affect tissue and cells in individuals with an abdominal aortic aneurysm (AAA) by lowering bad cholesterol (LDL-C) in the blood. Participants will receive either evolocumab injections or placebo injections to compare effects. The study seeks individuals who require open surgical repair for an AAA and are willing to follow the study procedures. As an Early Phase 1 trial, this research focuses on understanding how evolocumab works in people, offering participants the opportunity to contribute to groundbreaking medical knowledge.
Is there any evidence suggesting that evolocumab is likely to be safe for humans?
Previous studies have shown that evolocumab is safe. Research indicates that using evolocumab to lower LDL-C (bad cholesterol) is generally well-tolerated and does not cause major side effects. For example, one study found that early use of evolocumab significantly reduced LDL-C levels without increasing side effects. Additionally, no new safety issues emerged over time, and the rate of serious side effects was similar to those not taking the drug. These findings suggest that evolocumab is safe for patients, but individual health conditions should always be considered, and consultation with healthcare professionals is essential.12345
Why do researchers think this study treatment might be promising for AAA?
Unlike the standard treatments for abdominal aortic aneurysm, which typically involve monitoring or surgical interventions, Evolocumab offers a novel approach by targeting cholesterol levels. Evolocumab is a monoclonal antibody that inhibits PCSK9, a protein that affects the liver's ability to remove LDL cholesterol from the blood. By lowering LDL cholesterol, Evolocumab may reduce the stress on blood vessel walls, potentially slowing the aneurysm's growth. Researchers are excited about its potential to provide a non-surgical option that could complement existing management strategies for this condition.
What evidence suggests that evolocumab might be an effective treatment for abdominal aortic aneurysm?
In this trial, participants will receive either evolocumab or a placebo. Previous studies have shown that evolocumab, a PCSK9 inhibitor, reduces the size of abdominal aortic aneurysms (AAA). This suggests it might help manage AAA by possibly slowing its growth. Evolocumab also significantly lowers LDL-C, or "bad cholesterol," with some studies showing reductions up to 58%. Lowering LDL-C is believed to support heart health, which could benefit conditions like AAA. Although evolocumab is not typically used for AAA, its effects on cholesterol and inflammation suggest potential benefits for AAA patients.12678
Who Is on the Research Team?
Scott Damrauer, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Randomization
Baseline visit includes vital signs assessment, laboratory tests, medical history and medication review, pregnancy test (if applicable), and training on drug injections. Participants are randomized to receive either evolocumab or placebo.
Treatment
Participants receive 3 doses of evolocumab or placebo injections every 14 days for 5 weeks, starting 5 weeks prior to AAA repair. Injections can be performed at the site or at home under telehealth supervision.
AAA Repair and Tissue Collection
Participants undergo open AAA repair, repeat laboratory tests, and have a sample of aneurysm tissue taken.
Follow-up
Participants have a follow-up phone call 4 weeks after AAA repair to assess for any adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- Evolocumab
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Evolocumab is the drug that will be administered in this study. It will be administered as a 140mg subcutaneous injection every 14 days for 5 weeks (for a total of 3 doses).
This arm is a matching placebo that will be administered in the same fashion as the study drug if the patient is randomized to placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Evolocumab, a PCSK9 inhibitor, suppresses abdominal ...
Results: Aortic diameter was expanded in AAA-control compared with Sham. Treatment with evolocumab decreased the aneurysm size in the aortic wall compared ...
Real-World Insights Into Evolocumab Use in Patients With ...
From a real-world perspective, these data are consistent with the those from the HEYMANS European study, in which a 58% reduction in LDL-C was demonstrated ...
Disruption of PCSK9 Suppresses Inflammation and ...
Pcsk9 deletion attenuated AAA formation, improved survival, and decreased systemic inflammation, without altering circulating cholesterol levels.
4.
pennmedicine.org
pennmedicine.org/physicians-hub/physician-article/pcsk9-inhibitors-for-abdominal-aortic-aneurysmPCSK9 inhibitors for abdominal aortic aneurysm
To date, human clinical trials have found no consistent evidence of efficacy for angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, matrix ...
Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
Evolocumab is the drug that will be administered in this study. It will be administered as a 140mg subcutaneous injection every 14 days for 5 weeks (for a total ...
Disruption of PCSK9 Suppresses Inflammation and ...
Taken together, these results suggested that Pcsk9 deletion improved survival and attenuated AAA formation, independent of blood lipid changes.
Clinical Efficacy and Safety | Repatha® (evolocumab) HCP
Repatha + statin was proven to reduce the risk of composite CV events by 20% in a median of only 2.2 years, and the benefit improved over time in the study.
Safety and Effectiveness of Evolocumab During Acute and ...
Early evolocumab therapy initiation was associated with a significant decrease in LDL-C levels and was not associated with an increased risk of adverse effects ...
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