Clinical trial NCT06212271: Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Official title: A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Peripheral Artery Disease
Keywords: colchicine
atherosclerotic cardiovascular disease
peripheral artery disease
atherosclerosis
inflammation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2024-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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. 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

Primary outcomes:
measure: Molecular imaging markers of inflammation
timeFrame: Imaging (Week 4)
Secondary outcomes:
measure: Circulating markers of inflammation
timeFrame: Imaging (Week 4)
measure: Patient-reported walking impairment
timeFrame: Imaging (Week 4)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: