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A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Peripheral Artery Disease Clinical Trial

Official title:
A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Clinical Trial Summary

The goal of this mechanistic clinical trial is to test the effects of reducing inflammatory signaling in femoral artery atherosclerotic plaques. Researchers will compare patients receiving colchicine to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.

Clinical Trial Description

Patients with peripheral artery disease who will be undergoing femoral endarterectomy will be randomized 1:1 to receive colchicine (0.6mg oral) or placebo daily for 4 weeks prior to surgery. At the baseline visit, study procedures will be reviewed with eligible participants and the study team will obtain written informed consent. Baseline blood samples for laboratory studies will be collected and assayed. A urine pregnancy test will be done for women of childbearing age prior to starting study intervention. The study team will also obtain one 10 mL tube of research blood for future research. Participants will receive follow-up phone calls with the study team. All eligible participants will be approached for participation in an imaging visit. As part of this imaging visit, participants will undergo non-invasive molecular imaging to evaluate the effects of colchicine on the extent of atherosclerotic plaque macrophage activity as assessed by 18F-FDG PET/CT. At the time of femoral endarterectomy, participants will repeat laboratory tests and have a sample of the femoral artery plaque stored for analysis. Participants will then have a follow-up phone call after the femoral endarterectomy to assess for any adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06212271
Study type Interventional
Source University of Pennsylvania
Contact Thomas Carabuena
Phone 215-662-4830
Email thomas.carabuena@pennmedicine.upenn.edu
Status Not yet recruiting
Phase Early Phase 1
Start date May 2024
Completion date January 2026
View Details
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