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Looking for participantsPhase3

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

Sponsor: Population Health Research Institute

NCT ID: NCT04774159

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Colchicine 0.5 MG Oral Tablet (drug), Colchicine-Placebo (drug)
How long the study runs
Study runs about 103 months (dates as stated)
About the drug or intervention
Colchicine 0.5 MG Oral Tablet — drug: Colchicine 0.5 mg tablet daily Active drug and placebo are of the same appearance and are indistinguishable. · Colchicine-Placebo — drug: Colchicine-Placebo tablet
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether a low dose of colchicine, a medicine that reduces inflammation, can lower the remaining risk of blood vessel problems in people with peripheral artery disease. Peripheral artery disease (PAD) is a condition where arteries in the legs are narrowed by fatty build-up. The study is run by the Population Health Research Institute.

Who can take part

  • Adults over 18 years old
  • Symptoms of peripheral artery disease in the legs, such as pain when walking that eases with rest, with poor blood flow shown by tests
  • More severe leg problems such as rest pain in the foot, tissue death (necrosis), or gangrene, confirmed by blood flow tests
  • People who have had surgery or a procedure to improve blood flow to the leg, or an amputation of a leg or foot due to blood vessel disease
  • Some people with milder symptoms can join if they also have diabetes, heart failure, long-term kidney disease, or atherosclerosis in more than one part of the body
  • Written or verbal agreement (consent) to take part

Who may not be able to

  • People who cannot take colchicine for medical reasons
  • People who need to take colchicine long-term for another condition
  • People with active diarrhoea
  • Very reduced kidney function
  • Severe liver disease or cirrhosis
  • Women who are pregnant, breast-feeding, could become pregnant without reliable contraception, or are planning a pregnancy during the study
  • People taking or planning long-term use of certain medicines, including cyclosporine, verapamil, some HIV medicines, some antifungal medicines, or certain antibiotics (azithromycin is allowed)
  • People unlikely to return for follow-up visits
  • People with a life expectancy of less than one year

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
6,150
Started
2021-05-06
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for peripheral arterial disease
  • • Phase3 - 6,150 participants
  • • 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 take part?

  • • Ages 18 Years and over
  • • Diagnosed with peripheral arterial disease

Where?

  • • Brighton - Royal Sussex County Hospital
  • • Bristol - Southmead Hospital
  • • Canterbury - Kent and Canterbury Hospital
  • • Plymouth - Derriford Hospital
  • • +15 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The LEADER-PAD trial is a randomized, double blind, multicenter trial with an active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with symptomatic peripheral artery disease (PAD) to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation). The sample size for the trial is 6,150 participants. The primary outcome for the trial is major adverse cardiovascular and limb events (MACE and MALE). This composite outcome consists of cardiovascular death, myocardial infarction, stroke and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).

Peripheral Arterial DiseaseAtherosclerosis of ExtremitiesInflammation

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ an ankle/arm blood pressure ratio\* (ABI ≤ 0

What the study is looking for

  • ✓Age \> 18 years
  • ✓causing symptoms atherosclerotic LE PAD fulfilling at least one of the following:
  • ✓\* In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70...
  • ✓d. Leg or foot amputation for arterial vascular indications
  • ✓Written or verbal agreement to take part from the patient

Who cannot take part

  • ✗safety concern 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
See the full criteria
Inclusion criteria: 1. Age \> 18 years 2. Symptomatic atherosclerotic LE PAD fulfilling at least one of the following: a. Intermittent claudication with ankle/arm blood pressure ratio\* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. \>1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR \< 60 mL/min/1.73 m2) b. Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio\* (ABI ≤ 0.90) OR artery stenosis ≥ 50%. \* In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable c. Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery d. Leg or foot amputation for arterial vascular indications 3. Written or verbal informed consent from the patient Exclusion Criteria: 1. Contraindication to colchicine 2. Long term requirement for colchicine for another clinical indication 3. Active diarrhoea 4. eGFR \< 30 mL/min/1.73 m2 5. Cirrhosis or severe chronic liver disease 6. Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study 7. Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin) 8. Patients who are deemed unlikely to return for follow-up 9. Patients with life expectancy \< 1 year

Where Is This Study? (19 UK sites)

Royal Sussex County Hospital

Brighton, United Kingdom

Recruiting
Site contact (verified)
Mohamed Elahwal, MDPrincipal Investigator

Southmead Hospital

Bristol, United Kingdom

Recruiting
Site contact (verified)
Robert Hinchliffe, MDPrincipal Investigator

Kent and Canterbury Hospital

Canterbury, United Kingdom

Recruiting
Site contact (verified)
Sandeep Bahia, MDPrincipal Investigator

Derriford Hospital

Plymouth, United Kingdom

Recruiting
Site contact (verified)
Devender Mittapalli, MDPrincipal Investigator

Pinderfields Hospital

Wakefield, United Kingdom

Recruiting
Site contact (verified)
Patrick Coughlin, MDPrincipal Investigator

Royal Infirmary Edinburgh

Edinburgh, United Kingdom

Recruiting
Site contact (verified)
Rachael Forsythe, MDPrincipal Investigator

Bradford Teaching Hospital

Bradford, United Kingdom

Recruiting
Site contact (verified)
Kevin Mercer, MDPrincipal Investigator

Cambridge University Hospitals

Cambridge, United Kingdom

Recruiting
Site contact (verified)
Mohammed Chowdhury, MBChBPrincipal Investigator

Hull Royal Infirmary

Hull, United Kingdom

Recruiting
Site contact (verified)
Ian Chetter, MDPrincipal Investigator

The Leeds Teaching Hospital

Leeds, United Kingdom

Recruiting
Site contact (verified)
Marc Bailey, MDPrincipal Investigator

Glenfield Hospital

Leicester, United Kingdom

Recruiting
Site contact (verified)
Badri Vijaynagar, MDPrincipal Investigator

Royal Free London

London, United Kingdom

Recruiting
Site contact (verified)
Janice Tsui, MBBS, MDPrincipal Investigator

St. George's University Hospitals

London, United Kingdom

Recruiting
Site contact (verified)
Paul Moxey, MDPrincipal Investigator

St. Thomas Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Bijan Modarai, MBBSPrincipal Investigator

Manchester Royal Infirmary

Manchester, United Kingdom

Recruiting
Site contact (verified)
Tawqeer Rashid, MBBSPrincipal Investigator

Norfolk and Norwich University Hospitals

Norwich, United Kingdom

Recruiting
Site contact (verified)
Phil Stather, MDPrincipal Investigator

Sheffield Teaching Hospitals

Sheffield, United Kingdom

Recruiting
Site contact (verified)
Yousef Shahin, MDPrincipal Investigator

University Hospital Southampton

Southampton, United Kingdom

Recruiting
Site contact (verified)
Benjamin Patterson, MBBSPrincipal Investigator

Royal Cornwall Hospital

Truro, United Kingdom

Recruiting
Site contact (verified)
Abijheet Patil, MBBSPrincipal Investigator

How to Get in Touch

Noel C Chan, MD

Sponsor contact

CONTACT

905-521-2100 Noel.Chan@TAARI.CA

Sumathy Rangarajan

Sponsor contact

CONTACT

leaderpad@phri.ca
Data sourced from ClinicalTrials.gov · Last verified: 2026-03