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

NCT04774159 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6150

Last updated 2026-03-24

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Arterial Disease
  • Atherosclerosis of Extremities
  • Inflammation

Interventions

DRUG

Colchicine 0.5 MG Oral Tablet

Colchicine 0.5 mg tablet daily Active drug and placebo are of the same appearance and are indistinguishable. All investigators, study personnel and patients will be blinded to drug treatment assignment. Trial treatment supplies must be stored in a secure, limited-access location under the storage conditions specified on the IP supply label.

DRUG

Colchicine-Placebo

Colchicine-Placebo tablet

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Noel C Chan, MD · Population Health Research Institute, Hamilton, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Ecuador
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774159 on ClinicalTrials.gov