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Anti-inflammatory

Low-Dose Colchicine for Peripheral Artery Disease (LEADER-PAD Trial)

Phase 3
Recruiting
Led By Noel C Chan, MD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
History of symptomatic lower extremity PAD with one or more high risk features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

LEADER-PAD Trial Summary

This trial will test whether colchicine, an anti-inflammatory drug, can reduce the risk of vascular events in patients with peripheral artery disease.

Who is the study for?
This trial is for adults over 18 with symptomatic lower extremity peripheral artery disease (PAD) and certain high-risk features. It's not for pregnant or breastfeeding women, those without reliable contraception, people unlikely to return for follow-up, individuals with severe kidney or liver issues, active diarrhea, or those taking specific medications like cyclosporine.Check my eligibility
What is being tested?
The LEADER-PAD trial is testing if low-dose colchicine can reduce vascular events in PAD patients. Participants will either receive a colchicine tablet or a placebo to assess the effectiveness and feasibility of this anti-inflammatory treatment.See study design
What are the potential side effects?
Colchicine may cause side effects such as gastrointestinal discomfort (like nausea and diarrhea), blood disorders, muscle pain or weakness. Severe reactions are rare but can include serious infections due to lowered immunity.

LEADER-PAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.
Select...
I have had symptoms of poor blood flow in my legs with at least one high-risk feature.

LEADER-PAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean number of patients recruited per center per month
Secondary outcome measures
Adherence rate with colchicine at 12 months of follow-up
Proportion of patients undergoing successful randomization after the active run-in period
Rates of loss to follow-up and discontinuation rates after randomization
Other outcome measures
Gastrointestinal toxicity that leads to treatment interruption or discontinuation, infection (e.g., pneumonia) and incident cancer
Major Adverse cardiovascular and limb events (MACE or MALE).
Standard Assessment of Global Everyday Activities (SAGEA)
+1 more

LEADER-PAD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ColchicineActive Control1 Intervention
Colchicine 0.5mg daily for the duration of the trial
Group II: Colchicine-PlaceboPlacebo Group1 Intervention
Colchicine-Placebo daily

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
679,762 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
27,913 Patients Enrolled for Peripheral Arterial Disease
Noel C Chan, MDPrincipal InvestigatorPopulation Health Research Institute, Hamilton, Ontario, Canada

Media Library

Colchicine (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT04774159 — Phase 3
Peripheral Arterial Disease Research Study Groups: Colchicine-Placebo, Colchicine
Peripheral Arterial Disease Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT04774159 — Phase 3
Colchicine (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04774159 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are you looking for new participants in this research project?

"The clinicaltrials.gov website indicates that this study is still recruiting participants. The trial was originally posted on May 6, 2021 and was last updated on September 14, 2021."

Answered by AI

What are the odds of experiencing negative Colchicine side effects?

"Colchicine has undergone multiple rounds of testing with favorable results, thus it receives a safety score of 3."

Answered by AI

For what medical conditions is Colchicine most commonly prescribed?

"Colchicine is a medication used to mitigate gout flares and can also be useful in treating Behcet's syndrome, postcommissurotomy syndrome, and familial Mediterranean fever."

Answered by AI

Could you please explain what other research has been conducted using Colchicine?

"At the moment, there are 32 clinical trials investigating Colchicine. Out of those ongoing studies, 13 have reached Phase 3. The majority of these experiments are based in New york City; however, 190 different locations across the world are running similar trials."

Answered by AI

Who else is applying?

What site did they apply to?
Hamilton General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Noel Chan 2021. "Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774159.
All > Atherosclerosis > Pad
~38 spots leftby Apr 2025
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