Topline outcomes from the section three THALES trial, launched right this moment, present that in sufferers who had skilled an acute ischemic stroke or transient ischemic assault (TIA), the antiplatelet agent ticagrelor (Brilinta, AstraZeneca), together with aspirin, demonstrated a statistically important discount within the price of repeat stroke or dying in comparison with placebo.
THALES was performed in additional than 11,000 sufferers who had skilled a minor acute ischemic stroke or high-risk TIA and for whom therapy was initiated inside 24 hours of the onset of signs. The sufferers had been randomly assigned to obtain aspirin plus ticagrelor (90 mg twice day by day) or aspirin alone for 30 days.
The first endpoint ― the composite of stroke and dying at 30 days ― confirmed “a statistically important and clinically significant discount” within the ticagrelor group, AstraZeneca introduced.
The preliminary security findings “had been in line with the recognized profile of ticagrelor, with an elevated bleeding price within the therapy arm,” the corporate stated.
“The danger of getting a subsequent stroke is highest within the first few days and weeks after a minor acute ischemic stroke or high-risk transient ischemic assault,” Clay Johnston, MD, lead investigator for the THALES trial and dean of the Dell Medical College on the College of Texas at Austin, stated within the AstraZeneca launch. “Whereas an anticipated enhance in bleeding was noticed, the findings from THALES confirmed that ticagrelor, together with aspirin, lowered the chance of probably devastating occasions on this essential time.”
The total THALES trial outcomes will probably be offered at a forthcoming medical assembly.
These preliminary outcomes from THALES observe the POINT trial, which was reported in 2018. In that trial, a mixture of clopidogrel plus aspirin lowered main ischemic occasions, together with ischemic stroke, myocardial infarction, or dying from ischemic vascular causes, in contrast with aspirin alone in sufferers with minor ischemic stroke or high-risk TIA.
Though there was additionally a rise in bleeding with the twin antiplatelet remedy within the POINT trial, this was stated to be outweighed by the discount in ischemic occasions.
Whether or not the discount in ischemic occasions will even outweigh the elevated bleeding with ticagrelor within the THALES trial has not as but been revealed. This will probably be a serious focus of curiosity when the total outcomes are offered.
Johnston, who was additionally the lead investigator of the POINT trial, informed Medscape Medical Information that the THALES trial is designed equally to POINT however consists of some sufferers with extra extreme preliminary strokes. As well as, POINT required that sufferers be handled inside 12 hours of symptom onset, whereas THALES allowed enrollment inside as much as 24 hours.
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