Results from the Phase III THALES trial show that ticagrelor, when taken concomitantly with aspirin, produces a statistically significant and clinically meaningful reduction in stroke recurrences compared with aspirin treatment alone.
The randomized, placebo-controlled, double-blind, phase III, multicenter THALES trial was conducted in more than 11,000 patients who had a mild acute ischemic stroke or high-risk transient ischemic attack (TIA) in the 24 hours before treatment initiation [1].
BRILIQUE® meets primary endpoint
It was shown that a combination of aspirin with the active ingredient ticagrelor (BRILIQUE® 90 mg) twice daily for 30 days resulted in a stronger prophylactic effect than aspirin monotherapy. In the verum condition, an initial BRILIQUE® dose of 180 mg was administered on Day 1 followed by 90 mg twice daily on Days 2 through 30. All patients in the verum and placebo conditions received unblinded aspirin 300-325 mg on day 1, followed by 75-100 mg once daily on days 2 to 30. The primary efficacy end point was time to stroke or death within 30 days. The primary safety endpoint was time to first major bleeding event as defined by GUSTO*. Patients were observed on standard therapy for an additional 30 days. The preliminary safety results of the THALES study were consistent with the known profile of ticagrelor. The full THALES results will be presented at an upcoming medical conference.
Intervention in first 30 days after stroke is crucial
Stroke is the second leading cause of death worldwide [2]. In Switzerland, about 16 000 people suffer a stroke per year [3]. Those affected by acute ischemic stroke or TIA are at high risk for subsequent ischemic events, with the risk being particularly high within 30 days of the first event and highest in the first 24 hours after the first event [4]. Commenting on the THALES study results, Dr. Clay Johnston, THALES study director and dean of the Dell Medical School at the University of Texas at Austin, USA, said [1], “The risk of having another stroke is highest in the first days and weeks after an acute ischemic stroke or transient ischemic attack. While an increase in bleeding events was observed, as expected, the THALES results make it clear that BRILIQUE® in combination with aspirin reduced the risk of events with potentially devastating consequences during this critical period.” Ticagrelor is a direct-acting P2Y12 receptor antagonist that acts as an antiplatelet agent.
*GUSTO= Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries.
Source: AstraZeneca
Literature:
- Press Release: AstraZeneca, Baar, January 31, 2020, www.astrazeneca.com
- Roth GA, et al: Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: A systematic analysis for the Global Burden of Disease Study 2017. The Lancet 2018; 392(10159): 1736-1788.
- Swiss Neurological Society, https://swissneuro.ch/schlaganfall, last accessed Feb. 28, 2020.
- Khanevski AN, et al: Thirty-day recurrence after ischemic stroke or TIA. Brain Behav 2018; 8(10):e01108.
HAUSARZT PRAXIS 2020; 15(3): 33 (published 3/22/20, ahead of print).
