Dell Medical School, University of Texas at Austin, Austin, TX, USA.
Department of Neurology and Stroke Centre, Bichat Hospital, Paris Diderot, Paris, France.
Int J Stroke. 2019 Oct;14(7):745-751. doi: 10.1177/1747493019830307. Epub 2019 Feb 12.
In patients with acute cerebral ischemia, the rate of stroke, myocardial infarction, or death during 90 days was reported to be non-significantly lower with ticagrelor compared with aspirin, with no increase in major hemorrhage. Dual antiplatelet therapy may be more effective in this setting.
To investigate whether ticagrelor combined with aspirin are superior to aspirin alone in preventing stroke or death in patients with non-severe, non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial is a randomized, placebo-controlled, double-blind, event-driven study. Patients will be randomized within 24 h of onset of acute ischemic symptoms. THALES is expected to randomize 13,000 at ∼450 sites worldwide, to collect 764 primary outcome events. Study treatments are ticagrelor 180 mg loading dose on day 1, then 90 mg twice daily on days 2-30, or matching placebo. All patients will also receive open-label aspirin 300-325 mg on day 1, then 75-100 mg once daily on days 2-30.
The primary efficacy outcome is time to the composite endpoint of stroke or death through 30-day follow-up. The primary safety outcome is time to first severe bleeding event.
The THALES trial will provide important information about the benefits and risks of dual antiplatelet therapy with ticagrelor and aspirin in patients with acute cerebral ischemia in a global setting (funding: AstraZeneca).
http://www.clinicaltrials.gov . Unique identifier: NCT03354429.
在急性脑缺血患者中，与阿司匹林相比，替格瑞洛的 90 天内卒中、心肌梗死或死亡发生率报告无显著降低，但大出血发生率并未增加。在这种情况下，双联抗血小板治疗可能更有效。
研究替格瑞洛联合阿司匹林与单独应用阿司匹林相比，在预防非严重、非心源性缺血性卒中和高危短暂性脑缺血发作患者的卒中和死亡方面是否更有效。
急性卒中和短暂性脑缺血发作患者应用替格瑞洛和阿司匹林预防卒中和死亡（THALES）试验是一项随机、安慰剂对照、双盲、事件驱动的研究。患者将在急性缺血症状发作后 24 小时内随机分组。THALES 预计将在全球约 450 个地点随机入组 13000 例患者，以收集 764 例主要结局事件。研究治疗方案为替格瑞洛首日 180mg 负荷剂量，随后第 2-30 日每日 90mg 两次，或匹配安慰剂。所有患者还将在第 1 日接受开放标签的阿司匹林 300-325mg，随后第 2-30 日每日 1 次 75-100mg。
主要疗效结局是至 30 天随访时的卒中或死亡复合终点时间。主要安全性结局是至首次严重出血事件时间。
THALES 试验将在全球范围内提供关于替格瑞洛联合阿司匹林双联抗血小板治疗在急性脑缺血患者中的获益和风险的重要信息（资助：阿斯利康）。
