Low-dose colchicine for people with peripheral artery disease
2/2 Low dose colchicine in pAtients with peripheral artery DiseasE to assess residual vascular risk (LEADER-PAD)
People with peripheral artery disease will take a daily low-dose colchicine pill or a placebo to see if it lowers their risk of heart attacks, strokes, and limb problems.
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 ID | NIH-11399633 on NIH RePORTER |
What this research studies
You would be randomly assigned to take 0.5 mg of colchicine each day or a matching placebo, and neither you nor the study team would know which one you receive (double-blind). The U.S. effort plans to enroll 1,000 participants as part of a 6,150-person international, randomized, placebo-controlled trial led by Duke and partner centers. Study staff will follow participants with clinic visits and medical record checks to track heart attacks, strokes, limb events (such as procedures or amputations), and side effects. The trial tests whether a widely available, low-cost anti-inflammatory pill can lower vascular risks for people with PAD.
Who could benefit from this research
Good fit: Adults with a medical diagnosis of peripheral artery disease who can take an oral medication and attend scheduled study visits would be the best candidates.
Not a fit: People without PAD or those with contraindications to colchicine—such as severe kidney or liver disease, certain drug interactions, or pregnancy—may not be eligible or receive benefit.
Why it matters
Potential benefit: If successful, this common and inexpensive medicine could lower the chances of heart attacks, strokes, and serious limb complications in people with PAD.
How similar studies have performed: Large trials in people with coronary artery disease have shown colchicine reduced combined cardiovascular events by about 25%, but a large dedicated PAD trial like this is new.
Where this research is happening
Durham, United States
- Duke University — Durham, United States (Active)
Researchers
- Principal investigator: Vemulapalli, Sreekanth — Duke University
- Study coordinator: Vemulapalli, Sreekanth
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 below.