LEADER-PAD UK
Research type
Research Study
Full title
Low dose colchicine in patients with peripheral artery disease to address residual vascular risk: a randomized trial (LEADER-PAD)
IRAS ID
1009217
Contact name
Robert Hinchliffe
Contact email
Clinicaltrials.gov Identifier
Research summary
Atherosclerosis is a disease that causes narrowing of the arteries including the heart, brain and legs. It is caused by chronic inflammation and may lead to heart attack, stroke and removal of the leg (amputation). Atherosclerosis in the legs is called peripheral arterial disease (PAD).
The main treatment of people with PAD is to try to reduce further damage to the arteries throughout the body, thereby preventing artery complications such as stroke, heart attack and amputation. These treatments include living a healthier lifestyle, statin medication, aspirin and blood pressure medication. Unfortunately, despite these treatments, people with PAD still have high risk of developing further artery complications.
Because people with atherosclerosis have chronic inflammation of the arteries, researchers think that a commonly used medication called colchicine that reduces inflammation (an anti-inflammatory) may prevent further artery damage and artery complications. Studies in people with atherosclerosis in the heart arteries have found that colchicine can reduce the number of people developing artery complications by around 1 in 5.
We plan to perform a large study (1,500 people in 20 hospitals) to find out whether colchicine can be taken by people with PAD and whether it will prevent further artery damage and complications. If colchicine was shown to be effective in preventing artery complications, it would be a really important treatment to offer people with PAD.
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). Participants will take the tablets daily and have follow-up visits or phone calls with the clinical team, every 6 months for up to 4 years.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0235
Date of REC Opinion
3 Oct 2024
REC opinion
Further Information Favourable Opinion