Introduction: The CONVINCE trial tested daily colchicine versus usual care after stroke among over 3,000 subjects for almost 3 years. The primary endpoint, including first recurrent ischaemic stroke, myocardial infarction, cardiac arrest or hospitalisation for unstable angina, was not significantly reduced in ITT analysis, despite lowering CRP levels. Stroke and cardiovascular events were reduced in on-treatment analyses. Inflammation may not be contributing to the vascular risk in all subjects.
Methods: In CASPER, participants need a persistently elevated hs-CRP level (> 1.0 mg/L) at least 4 weeks remote from an acute stroke, indicating on-going inflammation. The CASPER criterion renders approximately 50% of subjects eligible.
CASPER is a Phase III, randomised, double-blind, placebo-controlled, multi-centre superiority trial. Up to 1500 adults with an IS event (defined as non-haemorrhagic, non-cardiac and non-fatal) without major disability (modified Rankin score [mRS] ≤3) OR clinical TIA with brain imaging evidence of acute infarction and hs-CRP ≥ 1 mg/L at 4-52 weeks post-index event will be recruited from centres throughout Australia. Study treatment includes a ‘run-in phase’: single blind (masked to the participant) Colchicine 0.5mg tablet daily for 28 days and then the study treatment phase: double blind Colchicine 0.5mg tablet or matched placebo tablet once daily for a median of at least 36 months.
Results: The primary outcome measure is major adverse cardiovascular events (MACE); a composite of non-fatal stroke, Acute Coronary Syndrome (ACS), urgent unscheduled revascularisation and CV death at 36 months or later (event-driven endpoint). Secondary outcome measures health related quality of life and cost effectiveness.
Conclusion: This is the first RCT of low dose colchicine for secondary prevention in IS with persistent raised hs-CRP and is funded by the Australian MRFF.
Relevance to clinical practice or patient experience: The role of colchicine for secondary prevention of stroke remains unresolved.