Abstract | Background and Purpose: Methods: In a randomized, placebo-controlled, double-blind trial of patients with mild-to-moderate acute noncardioembolic ischemic stroke or high-risk transient ischemic attack, patients were randomized within 24 hours after symptom onset to a 30-day regimen of either ticagrelor plus aspirin or matching placebo plus aspirin. For the present analyses, we defined the efficacy outcome, major ischemic events, as the composite of ischemic stroke or nonhemorrhagic death, and defined the safety outcome, major hemorrhage, as intracranial hemorrhage or hemorrhagic death. Net clinical impact was defined as the combination of these 2 end points. Results: In 11 016 patients (5523 ticagrelor- aspirin and 5493 aspirin), a major ischemic event occurred in 294 patients (5.3%) in the ticagrelor- aspirin group and in 359 patients (6.5%) in the aspirin group (absolute risk reduction 1.19% [95% CI, 0.31%–2.07%]). Major hemorrhage occurred in 22 patients (0.4%) in the ticagrelor- aspirin group and 6 patients (0.1%) in the aspirin group (absolute risk increase 0.29% [95% CI, 0.10%–0.48%]). Net clinical impact favored ticagrelor- aspirin (absolute risk reduction 0.97% [95% CI, 0.08%–1.87%]). Findings were similar when different thresholds for disability were applied and over a range of predefined subgroups. Conclusions: Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03354429.
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Authors | S Claiborne Johnston, Pierre Amarenco, Maria Aunes, Hans Denison, Scott R Evans, Anders Himmelmann, Marianne Jahreskog, Stefan James, Mikael Knutsson, Per Ladenvall, Carlos A Molina, Sven Nylander, Joachim Röther, Yongjun Wang, THALES Investigators |
Journal | Stroke
(Stroke)
Vol. 52
Issue 11
Pg. 3482-3489
(11 2021)
ISSN: 1524-4628 [Electronic] United States |
PMID | 34477459
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Platelet Aggregation Inhibitors
- Ticagrelor
- Aspirin
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Topics |
- Adult
- Aged
- Aspirin
(administration & dosage)
- Cerebral Hemorrhage
(chemically induced, epidemiology)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Ischemic Attack, Transient
(drug therapy)
- Ischemic Stroke
(drug therapy)
- Male
- Middle Aged
- Platelet Aggregation Inhibitors
(administration & dosage)
- Ticagrelor
(administration & dosage)
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