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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
Must not have
Active diarrhoea
Creatinine Clearance < 15 ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing diarrhea.
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My kidney function is very low.
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I am not pregnant, breastfeeding, and use reliable contraception without planning to conceive.
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I cannot take colchicine due to health reasons.
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I have severe liver disease or cirrhosis.
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I need colchicine for another health condition.
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I am using or plan to use certain medications like cyclosporine or azole antifungals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major adverse cardiovascular and limb events (MACE or MALE)
Secondary study objectives
Acute or chronic limb-threatening ischemia
All revascularization coronary or cerebrovascular or lower limb or other peripheral revascularization)
Any thrombosis or thromboembolism (arterial and venous)
+11 more
Other study objectives
Bleeding
Infection (e.g., pneumonia) leading to hospitalization
Muscle pain (myalgia or myositis), that results in study drug discontinuation
+5 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
164 Previous Clinical Trials
712,364 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
~3337 spots leftby Apr 2029
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