Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT06212271
- Run by
- University of Pennsylvania
- People needed
- 24
- Starts
- 2024-09-25
- Expected to finish
- 2026-03-25
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >= 18 years
- Diagnosis of peripheral artery disease
- Stated willingness to comply with all study procedures and availability for the duration of the study
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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