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SOCRATES: Brilinta Flops in Stroke Prevention Study

— Top-line results showed no advantage over aspirin

MedpageToday

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Ticagrelor (Brilinta) isn't better secondary prevention for stroke patients than is aspirin, according to top-line results from the SOCRATES trial.

A 90-mg dose twice daily failed on the primary composite efficacy endpoint of time to first occurrence of any ischemic or hemorrhagic stroke, myocardial infarction, or death when compared with 100-mg aspirin twice daily in patients with acute ischemic stroke or transient ischaemic attack (TIA), drugmaker.

Although there were numerically fewer such events with ticagrelor, the trend did not reach statistical significance, a press release from the company said, adding that the safety profile of the drug was as expected from use in other indications.

The trial "enrolled a patient population that differs from the currently-approved indications," AstraZeneca noted in a statement announcing the top-line results. That population was people over age 40 years with an acute ischemic stroke (National Institutes of Health Stroke Scale score less than 5) or TIA (ABCD² score of at least 4) and symptom onset within 24 hours.

Numerical results from the study were not released. AstraZeneca said full analysis of SOCRATES will be presented at an unspecified stroke congress. The company also said it "will engage with regulatory agencies on the interpretation of the data."

Further expansion of the ticagrelor indication beyond acute coronary syndrome and prior myocardial infarction populations is still feasible, with the EUCLID trial in peripheral arterial disease expected out later this year.

From the American Heart Association: