Phase 3 Study Shows Ticagrelor Plus Aspirin Reduces Risk of Stroke, Death

January 27, 2020

Ticagrelor (Brilinta, AstraZeneca) reduced the risk of stroke and death when taken with aspirin compared with aspirin alone.

Treatment with ticagrelor (Brilinta, AstraZeneca) plus aspirin reduced the risk of stroke and death when compared with aspirin alone, according to results from a phase 3 clinical study.

Ticagrelor is currently indicated to reduce the rate of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI.

When combined with aspirin, ticagrelor, an oral reversible direct-acting P2Y12 receptor antagonist, has been shown to significantly reduce the risk of major adverse CV events in patients with ACS or history of MI, according to AstraZeneca.

The phase 3 THALES trial, which included more than 11,000 patients, evaluated ticagrelor plus aspirin compared with aspirin alone in preventing the composite of stroke and death in patients with minor acute ischemic stroke or high-risk transient ischemic attack (TIA).

Within 24 hours of onset of acute ischemic stroke or high-risk TIA, patients were randomized and were followed-up for 30 days of treatment.

Patients received ticagrelor 180 mg loading dose on day 1, followed by 90 mg twice daily on days 2-30, or matching placebo. All patients in the study received open-label aspirin 300-325 mg on day 1, followed by 75-100 mg once daily on days 2-30.

According to the findings, ticagrelor 90 mg used twice daily and taken with aspirin for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared with aspirin alone.

The preliminary safety findings in the study were consistent with the known profile of ticagrelor, with an increased bleeding rate in the treatment arm, according to the data.

“The risk of having a subsequent stroke is highest in the first few days and weeks after a minor acute ischemic stroke or high-risk transient ischemic attack,” lead study investigator Clay Johnston, MD, PhD, dean of the Dell Medical School at The University of Texas at Austin, said in a statement. “While an expected increase in bleeding was observed, the findings from THALES showed that Brilinta, in combination with aspirin, reduced the risk of potentially devastating events in this crucial time.”

The full THALES trial results will be presented at a forthcoming medical meeting, according to AstraZeneca.

 

References:

1. Brilinta met primary endpoint in Phase 3 THALES trial in stroke [news release]. AstraZeneca’s website. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2020/brilinta-met-primary-endpoint-in-the-phase-iii-thales-trial-in-stroke-01272020.html. Accessed January 27, 2020.