NCT06212271

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 18F-FDG PET/CT imaging. 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, as well as additional blood samples for research. Participants will completed study questionnaires at baseline and at the imaging visit. Participants will receive follow-up phone calls with the study team. All eligible participants will be approached for participation in an imaging visit. At the imaging visit, participants will repeat laboratory tests and 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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Colchicine	See arm description.
DRUG	Placebo	See arm description.

Timeline

• Start date: 2024-09-25
• Primary completion: 2026-03-25
• Completion: 2026-03-25
• First posted: 2024-01-18
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States