Leader-Pad

Low dose colchincinE in pAtients with peripheral artery DiseasE to address residual vascular Risk

  • Funder: British Heart Foundation (Grant reference: CS/F/22/190051)
  • REC Number: 24/NW/0235
  • Status: Set-up
  • Sponsor: University of Bristol 
LEADER-PAD: Low dose colchincinE in pAtients with peripheral artery DiseasE to address residual vascular Risk

Study summary

The LEADER-PAD study aims to find out whether colchicine, an anti-inflammatory medication commonly used to treat gout, can be used by people with peripheral arterial disease to prevent heart attacks, strokes, leg gangrene and amputation.

Peripheral arterial disease (PAD) is caused by the accumulation of fatty deposits within an inflamed artery (blood vessel that carries blood away from the heart). The narrowing of arteries obstructs blood flow to the affected body parts. The legs are frequently affected and so are the heart and brain. The reduced blood flow to the legs can cause disabling leg pain and limit walking. Inflamed arteries are also prone to the sudden formation of blood clots, which can block the arteries and cause leg gangrene/amputation, heart attack and stroke.

The current treatments for PAD include surgery (to open up arteries), blood thinners, blood pressure pills and cholesterol lowering medications but about 5-30% of patients still end up with complications. These treatments do not primarily reduce inflammation, which causes arteries to get blocked. In the LEADER-PAD study, we will examine whether an anti-inflammatory medication, colchicine (0.5 mg/daily), will reduce vascular complications (like heart attack, stroke and amputation) in patients with PAD.

We have evidence that in patients who have had a heart attack or angina, colchicine reduces vascular complication rates by about 25%. People with PAD may benefit more because they have more build up in their arteries throughout their entire body but colchicine has not been studied in PAD.

This study is part of an international project being led by a team of researchers at the Population Health Research Institute (PHRI), a Joint Institute of Hamilton Health Sciences and McMaster University in Canada. The study will be conducted in other countries including Canada, Australia and the Netherlands.

The project as a whole aims to enrol 6,150 adults with PAD. Around 1,500 of these participants will be from the UK. Half will receive tablets containing the study medication colchicine and half will receive tablets containing a placebo (inactive medicine).

Further information

What does the study involve?

Patients referred to vascular department clinics or hospitalised with PAD will be eligible for the study. Participants who consent will be given colchicine for 2-3 weeks to make sure they can tolerate it and don’t experience unwelcome side effects. Participants who tolerate colchicine will then be randomly assigned to colchicine or a dummy pill (placebo).

People in the study will not know which type of pill they are taking. Participants will take the tablets daily for up to 4 years. Participants in each group will be followed up every 6 months for evaluation of clinical outcomes, including major cardiovascular and limb adverse events or hospitalisation for vascular complications or revascularisation. Participants will be asked to complete quality-of-life questionnaires annually.

For further information please see visit the study record on ISRCTN https://doi.org/10.1186/ISRCTN99954716

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