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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (19 UK sites)
Royal Sussex County Hospital
Brighton, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Pinderfields Hospital
Wakefield, United Kingdom
Royal Infirmary Edinburgh
Edinburgh, United Kingdom
Bradford Teaching Hospital
Bradford, United Kingdom
Cambridge University Hospitals
Cambridge, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
The Leeds Teaching Hospital
Leeds, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Royal Free London
London, United Kingdom
St. George's University Hospitals
London, United Kingdom
St. Thomas Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Norfolk and Norwich University Hospitals
Norwich, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
How to Get in Touch
Noel C Chan, MD
Sponsor contactCONTACT
Sumathy Rangarajan
Sponsor contactCONTACT
