Low-dose colchicine for peripheral artery disease to lower vascular risk
1/2 Low dose colchicine in pAtients with peripheral artery DiseasE to assess residual vascular risk (LEADER-PAD)
['FUNDING_OTHER'] · DUKE UNIVERSITY · NIH-11328633
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
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | DUKE UNIVERSITY (nih funded) |
| Locations | 1 site (DURHAM, UNITED STATES) |
| Trial ID | NIH-11328633 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: Adults diagnosed with peripheral artery disease who can take daily medication and meet the trial's eligibility and safety criteria would be ideal candidates.
Not a fit: 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.
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 performed: 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
DURHAM, UNITED STATES
- DUKE UNIVERSITY — DURHAM, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: PATEL, MANESH R — DUKE UNIVERSITY
- Study coordinator: PATEL, MANESH R
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.