A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Early Phase 1

Recruiting

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Colchicine; Drug: Placebo

• Registration Number: NCT06212271
• Lead Sponsor: University of Pennsylvania

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 surgery. 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. A urine pregnancy test will be done for women of childbearing age prior to starting study intervention. The study team will also obtain one 10 mL tube of research blood for future research. Participants will receive follow-up phone calls with the study team. All eligible participants will be approached for participation in an imaging visit. As part of this imaging visit, participants will 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. At the time of femoral endarterectomy, participants will repeat laboratory tests and have a sample of the femoral artery plaque stored for analysis. Participants will then have a follow-up phone call after the femoral endarterectomy to assess for any adverse events.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Study Start: 2024-09-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Symptomatic PAD
2. Require endarterectomy
3. Age > 18 years
4. 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. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study.
Placebo	Placebo	This arm is a matching placebo that will be administered in the same fashion as the experimental arm.

Primary Outcome Measures

Name	Time	Method
Molecular imaging markers of inflammation	Imaging (Week 4)	Extent of atherosclerotic plaque macrophage activity as assessed by FDG PET/CT

Secondary Outcome Measures

Name	Time	Method
Circulating markers of inflammation	Imaging (Week 4)	Expression of plasma IL6 and hsCRP levels
Patient-reported walking impairment	Imaging (Week 4)	Walking impairment as reported by Walking Impairment Questionnaire

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States