A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \>= 18 years
• Diagnosis of peripheral artery disease
• Stated willingness to comply with all study procedures and availability for the duration of the study
Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Clinical Research Coordinator
avi.patel@pennmedicine.upenn.edu
215-662-4830
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2026-01
Participants
Target number of participants: 24
Treatments
Experimental: Colchicine
Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study.
Placebo_comparator: Placebo
This arm is a matching placebo that will be administered in the same fashion as the experimental arm.
Related Therapeutic Areas
Sponsors
Collaborators: Doris Duke Charitable Foundation
Leads: University of Pennsylvania