Health TrialsbyHealthPanel

Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

ConditionAbdominal Aortic Aneurysm
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Abdominal aortic aneurysm (AAA) requiring open surgical repair

Age > 18

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Disqualifiers

Prior use of a PCSK9 inhibitor (evolocumab, alirocumab, inclisiran) within 6 months of the baseline visit

LDL-C < 40 mg/dL (within 3 months of baseline visit)

Known allergy to PCSK9 inhibitor

Aortic dissection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Evolocumab

    Drug

    See arm description.

  • Placebo

    Drug

    See arm description.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: EvolocumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Interleukin (IL)-6 in myeloid derived monocytes/macrophages from in AAA tissue

IL-6 expression will be measured in myeloid cells in the aortic tissue specimens using single nucleus RNA sequencing and confirmed by whole tissue ELISA.

Time frame
AAA Repair (Week 5)

Secondary outcomes

1

Matrix metalloproteinase (MMP)-9 in myeloid derived monocytes/macrophages from in AAA tissue

MMP-9 expression will be measured in myeloid cells in the aortic tissue specimens using single nucleus RNA sequencing and confirmed by whole tissue ELISA and immunofluorescence activity assays.

Time frame
AAA Repair (Week 5)
2

Infiltrating immune cell composition and their activation/inflammatory states in AAA tissue

Relative numbers of infiltrating immune cell type and their activation/inflammatory state as measured by a combination of bulk and single nuclear RNA sequencing

Time frame
AAA Repair (Week 5)
3

Smooth muscle composition of AAA tissue

The relative numbers of smooth muscle cells and their contractile/proliferative state as measured by a combination of bulk and single nucleus RNA sequencing

Time frame
AAA Repair (Week 5)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Amgen

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: