Despite high rates of optimal medical and surgical treatment, there is a demonstrated high risk of recurrent stroke. Inflammation of the lining of arteries is an important factor contributing to clots, leading to heart attacks and strokes. Current studies are testing medicines traditionally used for inflammation of joints (arthritis) to prevent strokes and heart attacks. CONVINCE is a clinical trial, testing colchicine in low doses, a medicine used for many years to treat gout and other joint disorders. The HRB Stroke Clinical Trials Network, led by Prof Kelly will compare colchicine to usual care (e.g. aspirin, cholesterol lowering medicines and blood pressure treatment) in a randomised fashion.
The primary aim is to compare low-dose colchicine plus usual care, to usual care alone, to prevent non-fatal recurrent ischaemic stroke and coronary events and vascular death after non-severe, non-cardioembolic TIA/stroke.
Secondary objectives will investigate safety of low-dose colchicine, and efficacy for each component of the primary outcome, fatal and non-fatal events, disabling and non-disabling stroke, effect modification by pre-specified subgroups, and impact on direct health care costs, adjusted for quality-adjusted life years.
The trial will be taking place in 18 countries across Europe and beyond, including 140 centres with a target recruitment of 3,154 patients. Participating countries include Ireland, Belgium, Canada, Czech Republic, Denmark, Estonia, Germany, Greece, Israel, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Republic of Northern Macedonia, Spain, Switzerland, UAE, and the UK (excluding Norther Ireland). Sites in four countries are actively recruiting so far, with seven more countries coming on stream during 2018 and the remainder in 2019.
If the trial is ‘positive’ it will lead to a major step forward in our treatment options for preventing stroke, heart attack, and death in survivors of non-disabling stroke and transient ischaemic attack (mini-strokes).
Benefit/activity within the defined area: Seeks to recruit 200 additional patients to an existing trial by expanding the trial (that includes UK and Ireland but not yet from within the Defined Area) into 5 centres in the Stroke/NI Clinical Research Network and 4 border hospitals in the ROI. Additional patients needed to power the study after a rate change revised the power calculation.
