Low-dose colchicine to reduce vascular risk in people with peripheral artery disease
Official title: 2/2 Low dose colchicine in pAtients with peripheral artery DiseasE to assess residual vascular risk (LEADER-PAD)
Funded at Duke University · NIH-11624874 · Data updated 2026-11-12
This project tests whether taking a low-dose anti-inflammatory drug (colchicine) daily can lower heart and limb-related risks for adults with peripheral artery disease.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | September 25, 2024 |
| Project end | August 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $139,952 |
| NIH project number | 3U24HL171356-03S1 |
| Project ID | NIH-11624874 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with peripheral artery disease who are potential participants in a multinational randomized trial.
✕Less likely to help
PAD patients who have contraindications to colchicine or do not meet trial criteria may not benefit.
What this research studies
This program centers on a large international trial called LEADER-PAD, focusing on people with PAD in the US. It tests a daily 0.5 mg colchicine versus placebo in a double-blind setup to see if reducing inflammation lowers cardiovascular and limb events. The US component is led by Duke Clinical Research Institute with a dedicated Clinical Coordination Center and Statistical/Data Coordination Center, working with patient advocates and international experts. If successful, the study could identify a readily available treatment to improve outcomes for PAD patients.
Why it matters
Potential benefit: If the approach works, patients with PAD could have fewer heart attacks, strokes, and limb complications through a simple daily medication.
How similar studies have gone: Previous trials in cardiovascular disease have suggested colchicine can reduce major adverse events, supporting this larger PAD-focused trial:
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Vemulapalli, Sreekanth — Duke University
- Study coordinator: Vemulapalli, Sreekanth
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.