Using low dose colchicine to reduce vascular risks in patients with peripheral artery disease
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-10982432 · Data updated 2026-11-12
This study is looking at whether a low dose of colchicine can help people with peripheral artery disease (PAD) by reducing the risk of heart problems, and we're inviting 1,000 participants from the U.S. to join us in this friendly trial where some will take the medication and others will take a placebo, all while we keep a close eye on their health.
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, 2025 |
| Funding year | 2024 |
| Award (this year) | $1,858,859 |
| NIH project number | 1UG3HL171357-01A1 |
| Project ID | NIH-10982432 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals diagnosed with peripheral artery disease who are at risk for cardiovascular events.
✕Less likely to help
Patients who do not have peripheral artery disease or those who are not at risk for cardiovascular complications may not benefit from this research.
What this research studies
This research investigates the effects of low dose colchicine on patients with peripheral artery disease (PAD) through a randomized, double-blind, placebo-controlled trial. The study aims to enroll 1,000 participants from the U.S. as part of a larger multinational effort to determine if this anti-inflammatory medication can lower the risk of cardiovascular events and complications related to PAD. Participants will receive either colchicine or a placebo daily, and their health outcomes will be closely monitored over the trial period. The research is led by a team of experienced investigators from Duke University, ensuring a robust approach to data collection and analysis.
Why it matters
Potential benefit: If successful, this research could significantly reduce the risk of heart attacks, strokes, and other serious complications for patients with peripheral artery disease.
How similar studies have gone: Previous studies have shown that colchicine can reduce cardiovascular risks in patients with coronary disease, indicating potential for success in this novel application for 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.
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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.
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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.