Testing colchicine for reducing inflammation in patients with peripheral artery disease
A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
EARLY_PHASE1 · University of Pennsylvania · NCT06212271
This study is testing if colchicine can help reduce inflammation in the arteries of people with peripheral artery disease.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Drugs / interventions | tocilizumab |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06212271 on ClinicalTrials.gov |
What this trial studies
This mechanistic clinical trial aims to evaluate the effects of colchicine on inflammatory signaling in atherosclerotic plaques in patients with peripheral artery disease. Participants will be randomized to receive either colchicine or a placebo for four weeks before undergoing 18F-FDG PET/CT imaging. The study will assess the impact of colchicine on macrophage activity within the plaques, using non-invasive imaging techniques. Blood samples and questionnaires will also be collected to gather additional data on the participants' health status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with peripheral artery disease who are willing to comply with study procedures.
Not a fit: Patients with recent use of colchicine or systemic anti-inflammatory medications, or those with certain medical conditions such as uncontrolled diabetes or autoimmune disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new anti-inflammatory treatments for patients with peripheral artery disease, potentially improving their outcomes.
How similar studies have performed: Other studies have shown promising results with colchicine in reducing inflammation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Levin, MD — University of Pennsylvania
- Study coordinator: Clinical Research Coordinator
- Email: avi.patel@pennmedicine.upenn.edu
- Phone: 215-662-4830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Artery Disease, colchicine, atherosclerotic cardiovascular disease, peripheral artery disease, atherosclerosis, inflammation