Status:
RECRUITING
Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
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 ima...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Diagnosis of peripheral artery disease
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion
- Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months
- Allergy to colchicine
- Presence of medication with drug-drug interaction
- Acute limb ischemia requiring emergent intervention
- Autoimmune/autoinflammatory disorders affecting blood vessels or with planned need for systemic anti-inflammatory medication
- Recent (\<14 days) systemic infection requiring hospitalization or ongoing treatment with antimicrobials
- History of persistent anemia, thrombocytopenia, or neutropenia requiring hematology/oncology treatment or felt to pose unacceptable risk to colchicine by the principal investigator
- Pregnant or lactating women
- History of uncontrolled diabetes or an A1C \>10% prior to the baseline visit
- History of CrCl \< 30 mL/minute or eGFR \< 30mL/minute or end-stage renal disease ESRD on dialysis
- History of liver disease or chronically-elevated (\>3 months) ALT/AST \> 3.0 x ULN
- Claustrophobia
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06212271
Start Date
September 25 2024
End Date
January 1 2026
Last Update
July 17 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104