FDA Broadens Ticagrelor Indication to Stroke Prevention

Megan Brooks


November 06, 2020

The US Food and Drug Administration (FDA) has approved the antiplatelet agent ticagrelor (Brilinta) to reduce the risk for stroke in patients with acute ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score of ≤5 or high-risk transient ischemic attack (TIA).

The new indication for stroke prevention is based on positive results from the phase 3 THALES trial, published in The New England Journal of Medicine last summer.

THALES was conducted in more than 11,000 patients who had experienced a minor acute ischemic stroke or high-risk TIA and for whom treatment was initiated within 24 hours of the onset of symptoms. The patients were randomly assigned to receive aspirin plus ticagrelor (90 mg twice daily) or aspirin alone for 30 days.

The trial demonstrated that ticagrelor plus aspirin reduced the rate of the primary composite endpoint of stroke and death by 17% (absolute risk reduction, 1.1%; hazard ratio, 0.83; 95% CI, 0.71 – 0.96; P = .015), compared to aspirin alone.

This was a statistically significant and clinically meaningful reduction. The primary composite endpoint was driven by a reduction in stroke, the company said in a news release.

The risk for severe bleeding events was 0.5% among patients taking aspirin plus ticagrelor and 0.1% for those taking aspirin alone. The results are in line with the known safety profile of ticagrelor, the company notes.

"One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days," Clay Johnston, MD, lead investigator for the THALES trial and dean of the Dell Medical School at the University of Texas in Austin, said in the company news release. "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."

Last spring, the FDA cleared ticagrelor for use with aspirin to cut the risk for a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease but no history of MI or stroke.

Ticagrelor is also indicated to reduce the risk for cardiovascular death, MI, and stroke in patients with acute coronary syndrome or a history of MI.

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