RECRUITING

Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-25
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06212271

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>= 18 years
  2. 2. Diagnosis of peripheral artery disease
  3. 3. Stated willingness to comply with all study procedures and availability for the duration of the study
  1. 1. Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months
  2. 2. Allergy to colchicine
  3. 3. Presence of medication with drug-drug interaction
  4. 4. Acute limb ischemia requiring emergent intervention
  5. 5. Vascular connective tissue disorders
  6. 6. Autoimmune/autoinflammatory disorders
  7. 7. Systemic infection
  8. 8. Blood dyscrasia
  9. 9. Pregnant or lactating women
  10. 10. Uncontrolled diabetes (A1C \>10%)
  11. 11. History of CrCl \< 30 mL/minute or ESRD (HD)
  12. 12. History of liver disease or chronically-elevated (\>3 months) ALT/AST \> 3.0 x ULN
  13. 13. Claustrophobia

Contacts and Locations

Study Contact

Clinical Research Coordinator
CONTACT
215-662-4830
avi.patel@pennmedicine.upenn.edu

Principal Investigator

Michael Levin, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Michael Levin, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Peripheral Artery Disease