Taking people in United KingdomPhase 3
Testing Low-Dose Colchicine for People With Peripheral Artery Disease
Tests a low dose of colchicine, an anti-inflammatory pill, in adults with narrowed leg arteries.
Key facts
- Who runs it
- Population Health Research Institute
- Where
- Bradford, Brighton, Bristol, Cambridge, Canterbury, Edinburgh, Hull, Leeds, Leicester, London, Manchester, Norwich, Plymouth, Sheffield, Southampton, Truro, and Wakefield, United KingdomSee the 19 sitesAlso in 10 other countries, 79 sites
- Trial code
- Registry title
- Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 6,150 people, planned
- Started
- 6 May 2021
- Expected to end
- Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Colchicine 0.5 MG Oral Tablet
- Colchicine-Placebo
- Record updated
- 5 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with peripheral artery disease in the legs who have symptoms. It tests whether low-dose colchicine, an anti-inflammatory drug, reduces vascular events.
- Age
- Older than 18 years
- Sex
- All sexes can join
- Disease stage
- Symptomatic atherosclerotic peripheral artery disease of the legs. This means leg pain when walking (with an ankle/arm blood pressure ratio of 0.90 or lower, or an artery narrowing of 50% or more, plus another condition such as diabetes, heart failure, chronic kidney disease or atherosclerosis in more than one vascular bed), or rest pain, tissue death or gangrene of the limb, or past leg bypass or artery-opening procedure, or past leg or foot amputation because of artery disease.
- Earlier treatment
- People who need colchicine long term for another reason cannot join. People who take or plan to take cyclosporine, verapamil, HIV protease inhibitors, azole antifungals or macrolide antibiotics (except azithromycin) long term cannot join.
- Biomarker or test result
- Ankle/arm blood pressure ratio of 0.90 or lower, or artery stenosis of 50% or more. If ankle arteries cannot be compressed, toe pressure of 60 mm Hg or lower, or toe-brachial index of 0.70 or lower.
Main reasons for not taking part
- Cannot take colchicine
- Active diarrhoea
- eGFR below 30 mL/min/1.73 m2
- Cirrhosis or severe chronic liver disease
- Pregnant or breast-feeding, or able to have children without reliable contraception
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Age > 18 years
- Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:; 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); 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; 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; Leg or foot amputation for arterial vascular indications
- Written or verbal informed consent from the patient
Who cannot take part
- Cirrhosis or severe chronic liver disease
- Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
- eGFR < 30 mL/min/1.73 m2
- Contraindication to colchicine
- Long term requirement for colchicine for another clinical indication
- Active diarrhoea
- Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
- Patients who are deemed unlikely to return for follow-up
- Patients with life expectancy < 1 year
Where in United Kingdom
Also in 10 other countries, 79 sites
- Bradford Teaching HospitalBradford, United KingdomContact: Kevin MercerTaking people
- Royal Sussex County HospitalBrighton, United KingdomContact: Abigail WhyteTaking people
- Southmead HospitalBristol, United KingdomContact: Seeve SuppiahTaking people
- Cambridge University HospitalsCambridge, United KingdomContact: Mohammed ChowdhuryTaking people
- Kent and Canterbury HospitalCanterbury, United KingdomContact: Vivian EdobhiyeTaking people
- Royal Infirmary EdinburghEdinburgh, United KingdomContact: Rachael ForsytheTaking people
- Hull Royal InfirmaryHull, United KingdomContact: Ian ChetterTaking people
- The Leeds Teaching HospitalLeeds, United KingdomContact: Marc BaileyTaking people
- Glenfield HospitalLeicester, United KingdomContact: Badri VijaynagarTaking people
- Royal Free LondonLondon, United KingdomContact: Janice TsuiTaking people
- St George's University HospitalsLondon, United KingdomContact: Paul MoxeyTaking people
- St Thomas HospitalLondon, United KingdomContact: Bijan ModaraiTaking people
- Manchester Royal InfirmaryManchester, United KingdomContact: Tawqeer RashidTaking people
- Norfolk and Norwich University HospitalsNorwich, United KingdomContact: Phil StatherTaking people
- Derriford HospitalPlymouth, United KingdomContact: Lisa ShainbergTaking people
- Sheffield Teaching HospitalsSheffield, United KingdomContact: Yousef ShahinTaking people
- University Hospital SouthamptonSouthampton, United KingdomContact: Benjamin PattersonTaking people
- Royal Cornwall HospitalTruro, United KingdomContact: Abhijeet PatilTaking people
- Pinderfields HospitalWakefield, United KingdomContact: Martin SylvesterTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ColchicineExisting treatment, for comparison
Colchicine 0.5mg daily for the duration of the trial
Treatment: Colchicine 0.5 MG Oral Tablet
- Colchicine-PlaceboPlacebo, for comparison
Colchicine-Placebo daily
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial
- Plain-language title
- Testing Low-Dose Colchicine for People With Peripheral Artery DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 October 2026