Why are we doing this study?
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 PAD 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).
If you are interested in taking part, your clinician will explain the study to you and check that you are suitable for the trial. If you do take part, you will be randomly allocated to take either colchicine or a dummy (placebo) tablet daily until the end of the study. Throughout the study, our hospital team will monitor your progress through regular clinic visits and phone check-ins, extending for up to four years. These assessments may include blood tests for safety monitoring and annual quality of life questionnaires.
Further information about taking part in the LEADER-PAD study can be found in the patient information leaflet below.
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