Top-line THALES results: Ticagrelor plus aspirin effective for secondary stroke prevention
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AstraZeneca announced that in the phase 3 THALES study, in patients with minor acute ischemic stroke or high-risk transient ischemic attack, twice daily ticagrelor 90 mg plus aspirin met the primary endpoint of reduced risk for stroke and death at 30 days compared with aspirin alone.
The phase 3 THALES trial included more than 11,000 patients who were treated with ticagrelor (Brilinta, AstraZeneca) 90 mg, an oral P2Y12 receptor antagonist that inhibits platelet activation, in combination with aspirin or aspirin plus placebo within 24 hours of minor acute ischemic stroke or high-risk TIA onset.
“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,” S. Claiborne Johnston, MD, lead investigator for the THALES trial and dean of the Dell Medical School at The University of Texas at Austin, said in the release. “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.”
Following minor acute ischemic stroke or high-risk TIA onset, patients were treated as soon as possible after randomization with ticagrelor 18 0mg and open-label aspirin 300 to 325mg on day 1. On days 2 to30, patients received ticagrelor 90 mg twice daily or placebo. All patients received aspirin 75 to 100 mg once daily on days 2 to30.
Preliminary safety findings were consistent with the known profile of ticagrelor 90 mg, with an increased risk for bleeding in the treatment arm, according to the release.
“We previously only had information from secondary analyses about this drug combination. Ticagrelor and clopidogrel have not been directly compared in this patient population,” Johnston told Healio. “As for any major clinical trial, it is important to see the entire presentation of the data, which will be forthcoming.”
Full results will be presented at an upcoming medical meeting, the company stated in the release.
“Results of the Phase III THALES trial showed Brilinta, in combination with aspirin, improved outcomes in patients who had experienced a minor acute ischemic stroke or high-risk transient ischemic attack,” Sir Mene Pangalos, PhD, executive vice president of BioPharmaceuticals research and development at AstraZeneca, said in the release. “We look forward to sharing the detailed results with health authorities.”
For more information:
S. Claiborne Johnston, MD, can be reached at elizabeth.roman@edelman.com.
Disclosures: Johnston reports he is the lead investigator on the THALES trial sponsored by AstraZeneca and has received research grants from AstraZeneca and nonfinancial support from Sanofi. Pangalos is an employee of AstraZeneca.