CompletedEarly Phase 1

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

United States24 participantsStarted 2024-09-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Molecular imaging markers of inflammation

Timeframe: Imaging (Week 4)

Trial details

NCT IDNCT06212271

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-25

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