🏛️ Verified NIH Record • Updated 2026-03-20

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk (NCT04774159)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Population Health Research Institute

🩺 Plain-English Summary (8th-Grade Level)

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (10 items).

Location: Yale School of Medicine — New Haven, Connecticut

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Contraindication to colchicine
  • Long term requirement for colchicine for another clinical indication
  • Active diarrhoea
  • eGFR \< 30 mL/min/1.73 m2
  • Cirrhosis or severe chronic liver disease
  • Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
  • Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
  • Patients who are deemed unlikely to return for follow-up
  • Patients with life expectancy \< 1 year

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (70 Sites)

  • Yale School of Medicine — New Haven, Connecticut
  • University of Florida - Gainesville — Gainesville, Florida
  • Tampa General Hospital — Tampa, Florida
  • University of Chicago Medical Center — Chicago, Illinois
  • Henry Ford Health System — Detroit, Michigan
  • Mayo Clinic — Rochester, Minnesota
  • Rutgers University — Newark, New Jersey
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
  • Duke Regional Hospital — Durham, North Carolina
  • Duke University Medical Center — Durham, North Carolina
  • Duke Raleigh Hospital — Raleigh, North Carolina
  • Ohio State University Wexner Medical Center — Columbus, Ohio
  • Vanderbilt University Medical Center — Nashville, Tennessee
  • Southwest Family Medicine — Dallas, Texas
  • University of Texas Southwestern Medical Center — Dallas, Texas
  • Texas Tech University Health Sciences — Lubbock, Texas
  • Sentara Norfolk General Hospital — Norfolk, Virginia
  • University of Washington Medical Center — Seattle, Washington
  • Medical College of Wisconsin — Milwaukee, Wisconsin
  • Sir Charles Gairdner Hospital — Perth, Western Australia
  • Universitair Ziekenhuis Leuven — Leuven,
  • Clínica Procárdio — Blumenau, Santa Catarina
  • Sociedade Hospitalar Angelina Caron — Campina Grande do Sul,
  • Hospital Universitário (CoraCentro Pesquisa Clinica) — Canoas,
  • Incore — Dois Vizinhos,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗