对血小板聚合功能的随机对照试验的协议,以指导缺血性中风的精确抗血小板治疗:PATH STROKE研究的理由和设计
Cerebrovascular diseases (Basel, Switzerland)
|December 19, 2025
概括
这项研究测试了基于血小板功能指导的抗血小板治疗是否可以降低缺血性中风患者的高治疗时血小板反应率 (HOPR). 精准医学方法可以改善中风幸存者的结果.
科学领域:
- 神经学 神经学
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 对阿司匹林的高治疗血小板反应性 (HOPR) 在缺血性中风患者中很常见.
- HOPR与"阿司匹林耐药性"和复发性血管事件的更高风险有关.
- 以血小板功能测试为指导的个性化抗血小板疗法可以提高中风预防.
研究的目的:
- 评估以血小板功能为指导的精确抗血小板治疗策略.
- 为了比较指导疗法与非心血管栓塞性缺血性中风的标准阿司匹林单疗法.
- 为了评估HOPR在随机化后30天的初级结果.
主要方法:
- PATH STROKE试验是一个多中心的,前性的,随机的,受控的,开放的标签,盲目的终点 (PROBE) 研究.
- 1018名最近接受阿司匹林治疗的缺血性中风患者被随机分为1:1接受指导治疗或标准护理.
- 针对HOPR患者 (≥35%的最大聚合率) 的指导治疗调整了抗血小板药物 (克洛皮多格雷尔,提卡格雷勒).
主要成果:
- 主要结局是30±5天后HOPR的比率.
- 二次结局包括主要缺血事件,中风发生 (缺血/出血),生活质量和出血事件 (BARC标准).
结论:
- "路径中风"是第一个评估以血小板功能为指导的精密药物策略的临床试验,用于二次中风预防.
- 这种方法旨在优化抗血小板治疗的有效性,并减少复发性缺血事件.
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