Low-dose colchicine for reducing vascular risk in people with PAD
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-11417947 · Data updated 2026-11-12
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.
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) | $1,812,133 |
| NIH project number | 5UH3HL171357-03 |
| Project ID | NIH-11417947 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults diagnosed with peripheral artery disease who meet trial inclusion criteria and are able to participate in a multicenter randomized trial.
✕Less likely to help
Patients who do not respond to colchicine, have contraindications to anti-inflammatory medications, or do not meet enrollment criteria may not benefit.
What this research studies
This project focuses on people with PAD to see if taking a small daily amount of colchicine reduces heart attacks, strokes, and limb problems. It enrolls about 1,000 US participants out of a planned 6,150 worldwide in a double-blind, placebo-controlled trial. The trial is organized with experienced clinical and statistical centers and includes patient advocates to guide the study. If successful, it could show a simple, widely available medicine helps lower vascular risk in PAD patients.
Why it matters
Potential benefit: If successful, patients with PAD could gain a simple treatment option to lower the risk of cardiovascular and limb events.
How similar studies have gone: Prior evidence suggests anti-inflammatory treatment may reduce cardiovascular events, but this is a large, multinational confirmation focused 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
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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.
-
IMProving mobility After revasCularizaTion in Peripheral Artery Disease
This study tests whether home-based exercise plus a nitrate supplement can help people with leg artery disease walk farther after a vascular procedure.
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.