This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone. To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis
Inflammation is a key pathophysiological contributor to unstable atherosclerotic plaque and thrombo-embolic events, stroke, myocardial infarction, and vascular death. Internationally, clinical trials are targeting atherosclerotic inflammation in patients with coronary disease using methotrexate, colchicine, and canukinumab. Aims: The primary aim is to compare low-dose colchicine (0.5mg/day) plus usual care, to usual care alone, to prevent non-fatal recurrent ischaemic stroke and coronary events and vascular death after non-severe, noncardioembolic 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 prespecified subgroups, and impact on direct health care costs, adjusted for quality-adjusted life years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,154
Uza, Antwerpen
Antwerp, Belgium
AZ Sint Jan
Bruges, Belgium
AZ St. Lucas, BRUGGE
Bruges, Belgium
UCL, Brussels
Brussels, Belgium
UZ Brussel
Brussels, Belgium
UZ Gent
Ghent, Belgium
Recurrence of non-fatal ischemic stroke
Any recurrence of non-fatal ischemic stroke
Time frame: any time within 60 month
on-fatal Major Cardiac event
Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest
Time frame: any time within 60 months
Vascular death
Fatal ischemic stroke, myocardial infarction, cardiac arrest
Time frame: 60 months
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AZ Groeninge Kortrijk
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
CHC Liege
Liège, Belgium
AZ Damiaan, OOSTENDE
Ostend, Belgium
...and 135 more locations