Introduction: The CONVINCE trial tested daily colchicine (0.5mg) versus usual care post-stroke in over 3,000 subjects with a median follow-up of nearly three years. The primary endpoint included recurrent ischemic stroke, myocardial infarction, cardiac arrest, or hospitalization for unstable angina. ITT analysis showed no significant reduction with colchicine, despite lowering CRP levels. However, on-treatment analysis and a subgroup with prior coronary disease showed reduced stroke and cardiovascular events. Inflammation may not uniformly contribute to vascular risk among all subjects.
Methods: CASPER selects participants with persistently elevated hs-CRP levels (≥1.0 mg/L) at least four weeks after an acute stroke, indicating ongoing inflammation and vascular risk. About 50% of subjects meet this criterion. CASPER is a Phase III, randomised, double-blind, placebo-controlled trial. Up to 1,500 adults with a non-haemorrhagic, non-cardiac, non-fatal ischaemic stroke (IS) 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 30 centres in Australia. The study includes a 'run-in phase' with single-blind colchicine (0.5mg daily for 28 days), followed by a double-blind phase with colchicine or placebo for at least 36 months.
Results: The primary outcome is major adverse cardiovascular events (MACE), including non-fatal stroke, acute coronary syndrome (ACS), urgent revascularization, and cardiovascular death at 36 months or later. Secondary outcomes include health-related quality of life, and cost-effectiveness.
Conclusion: This is the first RCT of low-dose colchicine for secondary prevention in IS patients with persistently raised hs-CRP, funded by the Australian MRFF.