A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Peripheral Artery Disease Clinical Trial

Official title:

A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212271
• Other study ID #: 854429
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Thomas Carabuena
• Phone: 215-662-4830
• Email: thomas.carabuena[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Colchicine
See arm description.
• Placebo
See arm description.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NLRP-3 inflammasome transcripts in femoral artery plaque specimens	Expression of NLRP-3 inflammasome transcripts will be measured using RNA sequencing	Femoral endarterectomy (Week 4)
Secondary	Plasma IL6 and hsCRP levels	Expression of plasma IL6 and hsCRP levels will be measured using RNA sequencing	Femoral endarterectomy (Week 4)
Secondary	Atherosclerotic plaque macrophage activity	Atherosclerotic plaque macrophage activity will be assessed by 18F-FDG PET/CT	Femoral endarterectomy (Week 4)