Low-dose colchicine for peripheral artery disease (LEADER-PAD)
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 low daily dose of colchicine or a placebo to try to lower the chance 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-11197610 on NIH RePORTER |
What this research studies
If you join, you would be randomly assigned to take 0.5 mg of colchicine each day or a matching placebo, and neither you nor your doctors would know which pill you get. The trial is double-blind and placebo-controlled and will follow participants for cardiovascular and limb-related outcomes like heart attack, stroke, and amputation. The U.S. will enroll about 1,000 of the planned 6,150 international participants, coordinated by Duke and the Population Health Research Institute. The idea is to test whether a widely available anti-inflammatory medicine can lower the high risk of heart and limb events that people with PAD face.
Who could benefit from this research
Good fit: Adults with a confirmed diagnosis of peripheral artery disease who meet the study's health criteria and can attend follow-up visits are the intended candidates.
Not a fit: People without PAD, those allergic to colchicine, or those with medical contraindications (for example severe kidney or liver disease or interacting medications) may not benefit or may be ineligible.
Why it matters
Potential benefit: If successful, this could reduce heart attacks, strokes, and limb complications for people living with PAD.
How similar studies have performed: Previous randomized trials in people with coronary artery disease showed low-dose colchicine reduced major cardiovascular events, but this is the first large randomized trial focused specifically on PAD.
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.