Low-dose colchicine for peripheral artery disease to lower vascular risk
Official title: 1/2 Low dose colchicine in pAtients with peripheral artery DiseasE to assess residual vascular risk (LEADER-PAD)
Funded at Duke University · NIH-11328633 · Data updated 2026-11-12
People with peripheral artery disease will take a daily low-dose colchicine pill or a matching placebo to try to reduce heart attacks, strokes, and limb complications.
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) | $1,841,946 |
| NIH project number | 4UH3HL171357-02 |
| Project ID | NIH-11328633 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults diagnosed with peripheral artery disease who can take daily medication and meet the trial's eligibility and safety criteria would be ideal candidates.
✕Less likely to help
People without PAD, those with contraindications to colchicine (for example severe kidney or liver disease or unsafe drug interactions), or those unwilling to attend study visits are unlikely to benefit from participating.
What this research studies
If I join, I would be randomly assigned to take 0.5 mg of colchicine each day or a placebo, and neither I nor the doctors would know which I am taking. The trial is double-blind and placebo-controlled and will enroll about 1,000 participants in the U.S. as part of a larger 6,150-person international effort. Researchers will track heart-related and limb-related events over follow-up visits coordinated by an experienced trial team based at Duke and partner centers. The goal is to find out whether this widely available anti-inflammatory pill can lower the risk of major cardiovascular and limb complications in people with PAD.
Why it matters
Potential benefit: If successful, this could provide an inexpensive, widely available pill to lower heart attack, stroke, and limb event risk for people with PAD.
How similar studies have gone: Previous trials in people with coronary artery disease have shown colchicine reduced major cardiovascular events by about 25%, but this is one of the first large trials focused specifically on PAD.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Patel, Manesh R — Duke University
- Study coordinator: Patel, Manesh R
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.
-
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.