Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Description

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

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Study Overview

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Study Details

Study overview

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.

A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Condition
Peripheral Artery Disease
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age \>= 18 years
  • 2. Diagnosis of peripheral artery disease
  • 3. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 1. Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months
  • 2. Allergy to colchicine
  • 3. Presence of medication with drug-drug interaction
  • 4. Acute limb ischemia requiring emergent intervention
  • 5. Vascular connective tissue disorders
  • 6. Autoimmune/autoinflammatory disorders
  • 7. Systemic infection
  • 8. Blood dyscrasia
  • 9. Pregnant or lactating women
  • 10. Uncontrolled diabetes (A1C \>10%)
  • 11. History of CrCl \< 30 mL/minute or ESRD (HD)
  • 12. History of liver disease or chronically-elevated (\>3 months) ALT/AST \> 3.0 x ULN
  • 13. Claustrophobia

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Michael Levin, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2026-01