Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

NCT06212271 | Completed Early Phase 1

• 1 other identifier: 854429
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.

Conditions

Peripheral Artery Disease

Keywords

colchicine; atherosclerotic cardiovascular disease; peripheral artery disease; atherosclerosis; inflammation

Outcome Measures

Primary Outcomes (1)

• Molecular imaging markers of inflammation

  Extent of atherosclerotic plaque macrophage activity as assessed by FDG PET/CT

  Imaging (Week 4)

Secondary Outcomes (2)

• Circulating markers of inflammation

  Imaging (Week 4)

• Patient-reported walking impairment

  Imaging (Week 4)

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study.

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

This arm is a matching placebo that will be administered in the same fashion as the experimental arm.

Drug: Placebo

Interventions

Colchicine DRUG

See arm description.

Colchicine

Placebo DRUG

See arm description.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Michael Levin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: September 25, 2024
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)