AstraZeneca has reported detailed results from the Phase III THALES clinical trial of Brilinta (ticagrelor) in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA).
Data showed that a 90mg dose of the drug taken twice-daily with aspirin for 30 days reduced the rate of the primary composite endpoint of stroke and death by 17% compared to aspirin alone.
These results are said to indicate a statistically significant and clinically meaningful decrease.
In addition, Brilinta plus aspirin significantly decreased the rate of the first secondary endpoint of ischaemic stroke by 21% versus aspirin alone up to day 30.
AstraZeneca added that the risk for severe bleeding events was 0.5% in the combination therapy group and 0.1% with aspirin alone. This is consistent with the known safety profile of Brilinta.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Patients who had an acute ischaemic stroke or transient ischemic attack may experience a subsequent, potentially avoidable stroke.
“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.”
Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that inhibits platelet activation.
When given with aspirin, the drug was found to significantly reduce the risk of major adverse cardiovascular (CV) events in patients with acute coronary syndrome (ACS) or a history of heart attack.
Brilinta plus aspirin is indicated to prevent atherothrombotic events in adult with ACS or for patients with a history of myocardial infarction (MI) and a high atherothrombotic event risk.
THALES is a randomised, placebo-controlled, double-blinded, international, multi-centre, event-driven trial conducted in more than 11,000 patients from 28 countries.
The study assessed the superiority of aspirin plus Brilinta in preventing the composite of stroke and death in patients with non-cardioembolic acute ischaemic stroke or high-risk TIA, compared to aspirin alone.
In January this year, AstraZeneca reported that the trial met its primary endpoint.