RecruitingEarly Phase 1NCT06212271

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

Sponsor

University of Pennsylvania

Enrollment

24 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Peripheral Artery Disease

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria12

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