Detailed results from a prespecified exploratory analysis of the positive THALES Phase III trial showed Brilinta (ticagrelor) 90mg, used twice daily and taken with daily aspirin for 30 days, reduced the rate of the composite of disabling stroke or death by 17% compared to aspirin alone; in patients who had an acute ischaemic stroke or transient ischaemic attack (TIA).
The rate of the composite of non-disabling stroke or death at 30 days was 1.3% in the aspirin plus ticagrelor group and 1.6% in the aspirin only group (HR 0.79 [95% CI 0.57, 1.08], p=0.140).
Following a recurrent stroke, patients treated with aspirin plus ticagrelor experienced a nominally significant reduction of disability burden compared to aspirin alone, based on an analysis of modified Rankin score (OR 0.77 [95%CI 0.65, 0.91], nominal p=0.002).
These new findings reinforce results of the Phase III THALES trial showing a statistically significant and clinically meaningful reduction in the composite of stroke or death at 30 days in patients with a stroke or TIA receiving aspirin plus ticagrelor versus aspirin alone.
Prof Pierre Amarenco, vice-chair of the THALES Executive Committee and Professor of Neurology at Paris University, said: “Until now, only aspirin had shown a significant reduction in disabling stroke during the first 90 days following an ischaemic stroke in a single trial. These new findings from THALES show that aspirin plus ticagrelor could provide a clinically meaningful reduction of the composite of disabling stroke and death compared to aspirin alone at day 30 due to subsequent ischaemic stroke.”
Dr Clay Johnston, chair of the THALES Executive Committee and Dean of the Dell Medical School at The University of Texas in Austin, US, said: “Without early treatment, up to 10 per cent of people are at risk of a major stroke in the first month after a transient ischaemic attack or acute ischaemic stroke. The THALES trial demonstrated that the risk of the composite of stroke or death at 30 days was lower with aspirin-ticagrelor than with aspirin alone.”
