Phase 3 Peripheral Arterial Disease Trial, Recruiting NCT04774159 Sponsor: Population Health Research Institute Condition: Peripheral Arterial Disease
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Phase 3 Peripheral Arterial Disease Trial, Recruiting

NCT04774159
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged over 18 years
  • People who have been diagnosed with peripheral artery disease (narrowing of the arteries in the legs) that is causing symptoms, AND who meet at least one of the following conditions:
  • People who experience leg pain when walking (called claudication), where blood flow measurements in the ankle show reduced circulation OR where an artery is narrowed by 50% or more, AND who also have at least one of: atherosclerosis (artery hardening) affecting more than one area of the body, diabetes, heart failure, or reduced kidney function (confirm with trial site for specific kidney function levels)
  • People who have pain in their foot while resting, or tissue death or gangrene in a limb, with reduced blood flow measurements in the ankle OR an artery narrowed by 50% or more
  • People who have had surgery or a procedure to restore blood flow to a leg (such as bypass surgery or a procedure to open a blocked artery)
  • People who have had an amputation of a leg or foot due to poor blood supply to the limb
  • People who have given their consent to participate, either in writing or verbally

Who may not be able to join:

  • People who have a medical reason they cannot take the drug colchicine
  • People who already need to take colchicine long-term for another health condition
  • People who are currently experiencing ongoing diarrhoea
  • People whose kidneys are functioning at a significantly reduced level (confirm specific threshold with trial site)
  • People who have cirrhosis or severe long-term liver disease
  • Women who are pregnant, breastfeeding, planning to become pregnant during the study, or of childbearing age who are not using reliable contraception
  • People who currently use or plan to use long-term certain medications, including cyclosporine, verapamil, some HIV medications, some antifungal medications, or most macrolide antibiotics (with the exception of azithromycin) — confirm with trial site if a specific medication is relevant
  • People who are considered unlikely to attend follow-up appointments
  • People whose life expectancy is less than one year

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Noel C Chan, MD, Population Health Research Institute, Hamilton, Ontario, Canada

Phone: 905-521-2100

Australian sites

Sir Charles Gairdner Hospital, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Population Health Research Institute
Registry
ClinicalTrials.gov
Start date
6 May 2021
Est. completion
1 December 2029

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada Ecuador 🇳🇱 Netherlands 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Major adverse cardiovascular and limb events (MACE or MALE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov