Ticagrelor DAPT Approved by FDA for Reducing Stroke Risk

AstraZeneca has announced the US Food and Drug Administration (FDA) has approved ticagrelor (Brilinta) for reducing the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA).

According to a statement from AstraZeneca, the approval from the FDA is based on the results of the THALES trial, which indicated dual antiplatelet therapy with aspirin plus ticagrelor 90 mg significantly reduced the rate of a composite endpoint of stroke and death when compared to aspirin alone.

“One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days. The approval of BRILINTA in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news for physicians and patients,” said S. Claiborne Johnston, MD, PhD, principal investigator of the THALES trial and dean of the Dell Medical School at the University of Texas at Austin, in the aforementioned statement.

With previous approvals dating back to 2011, the latest approval for ticagrelor further cements its role in treatment algorithms for multiple cardiovascular conditions. Conducted in a population of more than 11,000 patients, results of the phase 3 THALES trial demonstrated the P2Y12 inhibitor’s ability to reduce the rate of a primary composite endpoint of stroke and death by 17% (absolute risk reduction = 1.1%; HR, 0.83; 95% CI, 0.71-0.96; P=.015) when taken twice-daily with aspirin compared to aspirin alone in patients with an acute ischemic stroke or TIA.

Published in The New England Journal of Medicine, the study also indicated ticagrelor was not associated with a significant difference in the incidence of disability. Investigators noted severe bleeding events occurred in 0.5% of the ticagrelor group compared to 0.1% of those randomized to aspirin alone (HR, 3.99; 95% CI, 1.74-9.14; P=.001) during the trial, which is similar to the safety profile demonstrated in previous trials.

For more on the results of the THALES trial, check out this interview from July 2020 where Johnston sat down with Practical Cardiology to offer further insight into the phase 3 study.