Detailed results from an exploratory analysis of the THALES Phase III trial showed the medication Brilinta (ticagrelor) reduced the rate of the composite of disabling stroke or death.
Results from the positive THALES Phase III trial have demonstrated that 90mg of Brilinta, 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.
The results were presented alongside the full results from the THALES trial at the virtual European Stroke Organisation and World Stroke Organization Conference 2020 (ESO-WSO 2020) and have been published in JAMA Neurology.
Brilinta and aspirin
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.
Prof Pierre Amarenco, International Coordinating Investigator and 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.”
The risk for severe bleeding events in patients with disabling stroke was 0.4% in the aspirin plus ticagrelor group and 0.1% in the aspirin group, showing that the results were in line with the known safety profile of ticagrelor.
Dr Clay Johnston, International Coordinating Investigator and 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% 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.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The use and benefit of ticagrelor in cardiovascular disease is well established, and the same mode of action results in reducing the risk of a subsequent stroke. The THALES data presented at ESO-WSO 2020 further support the initial trial findings and reflect our commitment to transform patient outcomes in stroke by providing a new treatment option with the potential to deliver clinically meaningful improvements.”