Plain-English translation of NCT04774159 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
The LEADER-PAD trial is testing whether colchicine—a low-dose daily pill—can help prevent serious heart and leg complications in people with peripheral artery disease (poor blood flow in the legs caused by clogged arteries). Researchers believe this medication may reduce harmful inflammation in blood vessels. About 6,150 people will participate, and half will receive the medication while half receive a placebo (dummy pill).
People with peripheral artery disease are at high risk for heart attacks, strokes, and severe leg problems like gangrene or amputation, even when they receive standard care. This trial is testing whether this medication could lower that risk by calming the inflammation in blood vessels that contributes to these dangerous events.
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You will take either one low-dose pill of the medication or a placebo pill once daily for the duration of the trial. You'll return for regular follow-up visits where doctors will check on your health and watch for any heart, stroke, or leg complications. The trial will continue until enough participants have experienced events or until researchers have enough information to know if the medication works.
AI-generated summary from trial data · Aug 6, 2026 · Not medical advice
United States