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.
Plain-language title generated from the registry record
Registry title: Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Key facts
- Where
- Bradford, Brighton, Bristol, Cambridge, Canterbury, Edinburgh, Hull, Leeds, Leicester, London, Manchester, Norwich, Plymouth, Sheffield, Southampton, Truro, and Wakefield, United KingdomSee the 19 sites
- Phase
- Phase 3
Where in United Kingdom
- Bradford Teaching HospitalBradford, United KingdomTaking people
- Royal Sussex County HospitalBrighton, United KingdomTaking people
- Southmead HospitalBristol, United KingdomTaking people
- Cambridge University HospitalsCambridge, United KingdomTaking people
- Kent and Canterbury HospitalCanterbury, United KingdomTaking people
- Royal Infirmary EdinburghEdinburgh, United KingdomTaking people
- Hull Royal InfirmaryHull, United KingdomTaking people
- The Leeds Teaching HospitalLeeds, United KingdomTaking people
- Glenfield HospitalLeicester, United KingdomTaking people
- Royal Free LondonLondon, United KingdomTaking people
- St George's University HospitalsLondon, United KingdomTaking people
- St Thomas HospitalLondon, United KingdomTaking people
- Manchester Royal InfirmaryManchester, United KingdomTaking people
- Norfolk and Norwich University HospitalsNorwich, United KingdomTaking people
- Derriford HospitalPlymouth, United KingdomTaking people
- Sheffield Teaching HospitalsSheffield, United KingdomTaking people
- University Hospital SouthamptonSouthampton, United KingdomTaking people
- Royal Cornwall HospitalTruro, United KingdomTaking people
- Pinderfields HospitalWakefield, United KingdomTaking people
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?
Trial details
- Who runs it
- Population Health Research Institute
- Trial code
- NCT04774159
- Record updated
- 5 October 2026
- Original description
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.Read full original descriptionShow less
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized 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.
Inclusion: 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.
Exclusion: 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.