Colchicine in PAD

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Recruiting

18 years or above

All

Phase N/A

24 participants needed

1 Location

Brief description of study

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.

Detailed description of study

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 imaging. At the baseline visit, study procedures will be reviewed with eligible participants and the study team will obtain written informed consent. Baseline blood samples for laboratory studies will be collected and assayed, as well as additional blood samples for research. Participants will completed study questionnaires at baseline and at the imaging visit. Participants will receive follow-up phone calls with the study team. All eligible participants will be approached for participation in an imaging visit. At the imaging visit, participants will repeat laboratory tests and undergo non-invasive molecular imaging to evaluate the effects of colchicine on the extent of atherosclerotic plaque macrophage activity as assessed by 18F-FDG PET/CT.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Peripheral Artery Disease
Age: 18 years or above
Gender: All

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
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

This study investigates peripheral artery disease (PAD).

The study evaluates how the investigational medication affects inflammation in the arteries.

Who can participate: Adults aged 18 and older with peripheral artery disease who are willing to follow study procedures can participate. Those using certain anti-inflammatory medications or with specific medical conditions are excluded.
Study details: Participants will take either the investigational medication or a placebo for four weeks. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

Updated on 02 Apr 2026. Study ID: 23-1314

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