Low-dose colchicine for peripheral artery disease (LEADER-PAD)
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-11197610 · Data updated 2026-11-12
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 start | September 25, 2024 |
| Project end | August 31, 2029 |
| Funding year | 2025 |
| Award (this year) | $656,265 |
| NIH project number | 5U24HL171356-02 |
| Project ID | NIH-11197610 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Vemulapalli, Sreekanth — Duke University
- Study coordinator: Vemulapalli, Sreekanth
Related research
Other NIH-funded projects on the same topics.
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Low-dose colchicine to reduce vascular risk in people with peripheral artery disease
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.
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Gamified home walking program to help seniors with peripheral artery disease improve walking and quality of life
A program uses game elements on wearable devices to help people 65+ with peripheral artery disease walk more at home and feel better.
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Fatty clues in leg arteries: how fat burning in mitochondria affects PAD and muscle health
This project looks at how fat metabolism in leg muscles relates to weakness and tissue damage in people with peripheral artery disease and aims to find new ways to help them.
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Enhancing muscle energy to help leg function in PAD
A study to boost how muscle mitochondria work in people with peripheral artery disease to improve walking and leg function.
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Low-dose colchicine for people with peripheral artery disease to reduce heart and limb risks
A large international study will test whether a low daily dose of colchicine can lower heart and limb complications for people with peripheral artery disease.
-
Low-dose colchicine for reducing vascular risk in people with PAD
A large international study will test whether a daily low dose of colchicine can lower heart and limb-related risks for people with peripheral artery disease.
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.