Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

NCT ID: NCT06212271

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2026-01-31

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.

Detailed Description

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Colchicine

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

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

See arm description.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

See arm description.

Interventions

Colchicine

See arm description.

Intervention Type: DRUG

Placebo

See arm description.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

Exclusion Criteria

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. Autoimmune/autoinflammatory disorders affecting blood vessels or with planned need for systemic anti-inflammatory medication

6. Recent (<14 days) systemic infection requiring hospitalization or ongoing treatment with antimicrobials

7. History of persistent anemia, thrombocytopenia, or neutropenia requiring hematology/oncology treatment or felt to pose unacceptable risk to colchicine by the principal investigator

8. Pregnant or lactating women

9. History of uncontrolled diabetes or an A1C >10% prior to the baseline visit

10. History of CrCl < 30 mL/minute or eGFR < 30mL/minute or end-stage renal disease ESRD on dialysis

11. History of liver disease or chronically-elevated (>3 months) ALT/AST > 3.0 x ULN

12. Claustrophobia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Levin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Research Coordinator

Role: CONTACT

avi.patel@pennmedicine.upenn.edu

215-662-4830

Other Identifiers

854429

Identifier Type: -

Identifier Source: org_study_id