RecruitingPhase IIIInterventional

A study of the anti-inflammatory medication colchicine for people with blocked arteries of the legs

Peripheral arterial disease (PAD) develops when fatty build-up narrows the blood vessels supplying the legs. Even with healthy lifestyle changes, statins, and blood pressure pills, people with PAD still face a higher risk of heart attacks, strokes, or amputations. Doctors believe ongoing swelling inside the arteries, known as inflammation, plays a key role in causing this damage. The LEADER-PAD study is testing a low-dose tablet called colchicine to see if calming this inflammation provides extra protection. Colchicine is already widely used for gout and heart conditions. UK participants will first take colchicine for two to three weeks to ensure it suits them. Those who tolerate it will be randomly assigned to take either colchicine or a dummy pill (placebo) once daily for up to four years. The study aims to find out if this simple tablet can keep arteries healthier over time.

At a glance

Status

Recruiting

Phase

Phase III

Enrolment target

6,150

Start

07 May 2021

Estimated completion

01 Aug 2027

Peripheral artery disease

What is this study about?

Many people live with peripheral arterial disease, commonly called PAD. This condition occurs when blood vessels in the legs become narrow or hardened by fatty deposits. As blood flow drops, people often experience cramping pain when walking, sores that are slow to heal, or in severe cases, tissue damage that can lead to amputation. Because blood vessel narrowing often affects the entire body, people with PAD also face a higher chance of having a heart attack or stroke.

Standard NHS treatments currently include cholesterol-lowering statins, blood-thinning aspirin, and blood pressure tablets, alongside stopping smoking and exercising. While these treatments help, many people still experience worsening circulation. Researchers now recognise that long-term inflammation inside the blood vessel walls continues to cause harm. Finding a way to calm this swelling could be the missing piece in protecting patients' blood vessels.

Colchicine is an inexpensive, well-established medicine that has been used safely for decades to treat gout. Recent studies in people with heart disease showed that low doses of colchicine lowered the risk of major artery problems by about 20%. The LEADER-PAD study is now finding out whether colchicine can offer the same powerful protection to people with blocked leg arteries, helping them stay active and avoid serious illness.

Key takeaways

Tests whether low-dose colchicine can protect arteries and lower the risk of heart attacks, strokes, and amputations in people with PAD.
Funded in the UK by the British Heart Foundation, aiming to involve around 1,500 UK participants.
Includes a two- to three-week test run to make sure the tablet does not upset your stomach before you join the main study.
Participants take one tablet a day (either colchicine or a dummy pill) for up to four years.
Follow-up check-ins take place every six months, with many done conveniently by phone or post.

Who may be eligible?

This trial is open to adults aged 18 and over who have noticeable symptoms of peripheral arterial disease in their legs. This includes people who get calf pain or tightness while walking, people who have foot pain while resting, or those who have had past leg procedures such as stents, bypass surgery, or an amputation due to poor blood flow. Participants usually have another related health factor, such as diabetes, heart failure, kidney disease, or narrowed arteries elsewhere in the body.

To keep you safe, some people cannot take part. You will not be able to join if you have severe kidney or liver disease, ongoing diarrhoea, or are already taking colchicine regularly. Women who are pregnant, breastfeeding, or planning a pregnancy cannot participate. You may also be excluded if you take certain medicines that interact with colchicine, such as specific heart medications or particular antibiotics.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Have you been diagnosed with peripheral arterial disease (PAD) affecting your legs?
Do you get leg pain when walking, pain in your feet at rest, or have you had past surgery or stents for your leg circulation?
Are your kidneys and liver working reasonably well, and are you free from chronic diarrhoea?
Are you neither pregnant nor breastfeeding, and not planning to become pregnant during the trial?

Answer every question to see your result.

What does participation involve?

If you decide to join, your participation begins with a two to three-week test run. You will be given a small supply of colchicine tablets to see how your stomach tolerates them. If you take at least 11 tablets and feel comfortable, you will move on to the main part of the trial. In this stage, a computer will randomly assign you to take either colchicine or a dummy pill (placebo) once a day. Neither you nor your doctor will know which pill you are receiving.

You will stay in the study for up to four years, with check-ins every six months. The researchers have designed the trial to fit easily into daily life: many of these check-ups can be done over the phone or by filling out short questionnaires at home about your quality of life. The team will keep track of any hospital visits and your general leg symptoms, and you may be asked to have a routine blood test once a year.

Potential risks and benefits

Taking part may not directly improve your leg symptoms, but you will be contributing to research that could protect future patients from strokes, heart attacks, and amputations. Colchicine has been used for a very long time, but it can sometimes cause mild stomach upsets, such as loose stools (diarrhoea) or feeling sick. Because this trial uses a very low dose, these side effects are far less common, and the short test run at the start helps ensure you only continue if the tablet suits you well. Joining is completely your choice, and you can change your mind and leave the study at any time without it affecting your standard NHS care.

Locations (20)

Addenbrookes Hospital
City only
Cambridge, England
Royal Infirmary of Edinburgh at Little France
City only
Lothian, Scotland
Glenfield Hospital
Approximate
Leicester, England
Leeds General Infirmary
Approximate
Leeds, England
Bradford Royal Infirmary
Approximate
Bradford, England
Southampton General Hospital
Unverified
Southampton, England
Southmead Hospital
Unverified
Bristol, England
Northern General Hospital
Unverified
Sheffield, England
Royal Sussex County Hospital
Unverified
Brighton, England
St Georges Hospital
Unverified
London, England
Norfolk and Norwich University Hospital
Unverified
Norwich, England
Kent and Canterbury Hospital
Unverified
Canterbury, England

Common questions

What is a placebo?

A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers make a fair comparison to see if the real drug truly makes a difference.

Will I have to stop taking my normal PAD medications?

No. You will continue to take all your usual prescribed medicines, such as statins or blood pressure tablets, alongside the study tablet.

Do I have to travel to hospital for every check-up?

No. To make taking part as convenient as possible, many of the six-monthly check-ups can be carried out over the phone or through questionnaires completed at home.

What happens if I get an upset stomach from the tablets?

You should let the study team know straight away. If the tablets do not agree with you during the early test run, you will simply stop taking them and will not enter the main study.

Can I leave the study if I change my mind later?

Yes. Taking part is entirely voluntary. You are free to stop taking the study tablets and withdraw at any point, and your regular medical care will continue as normal.

How to find out more

Lucy Ellis

leaderpad-trial@bristol.ac.uk None provided Official trial record

Always speak to your GP or specialist before deciding to take part in a study.