Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Launched by UNIVERSITY OF PENNSYLVANIA · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a medication called colchicine on patients with Peripheral Artery Disease (PAD). The main goal is to see if colchicine can help reduce inflammation in the blood vessels, specifically in the femoral artery, which is often affected by a buildup of fatty deposits known as atherosclerotic plaques. Participants will be divided into two groups: one group will receive colchicine, while the other group will receive a placebo (a harmless substance with no active medication) to compare the results.

To be eligible for this study, you must be at least 18 years old and diagnosed with Peripheral Artery Disease. You should also be willing to follow the study procedures throughout the trial. However, there are some exclusions, such as recent use of colchicine or certain anti-inflammatory medications, allergies to colchicine, and specific health conditions like uncontrolled diabetes or liver disease. If you participate, you can expect to attend regular appointments where your health will be monitored, helping researchers understand how colchicine impacts inflammation in your arteries.

Gender

ALL

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