Results from the positive phase III THALES trial showed AstraZeneca’s Brilinta (ticagrelor) 90mg used twice daily and taken with daily aspirin for 30 days, reduced the rate of the primary composite endpoint of stroke and death by 17% (HR 0.83 [95% CI: 0.71, 0.96], p=0.02), compared to aspirin alone in patients who had an acute ischemic stroke or transient ischemic attack (TIA). These findings have been published in The New England Journal of Medicine.
The company note that this was a statistically significant and clinically meaningful reduction. Furthermore, aspirin plus Brilinta significantly reduced the rate of the first secondary endpoint of ischaemic stroke by 21%, compared to aspirin alone up to day 30. The risk for severe bleeding events was 0.5% in the aspirin plus Brilinta group and 0.1% in the aspirin group. The results were in line with the known safety profile of Brilinta.
Clay Johnston, lead investigator for the THALES trial and Dean of the Dell Medical School at The University of Texas in Austin, USA, said: “About one in four stroke survivors go on to experience a second stroke, and the risk is particularly high within the first month after the initial event. Early treatment is important to prevent a subsequent stroke that may be disabling or fatal. It is also expected to improve long-term outcomes.”
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, added: “Results from the Phase III THALES trial confirm that aspirin plus Brilinta has the potential to be a new effective treatment option for these high-risk patients and we look forward to continuing discussions with regulatory authorities.”
The company also states that currently, Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack. In May 2020, the US Food and Drug Administration (FDA) approved a label update for Brilinta in the USA to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.