辅助随机对照试验:理由和设计
Hongfei Sang1,2, Zhilin Zheng1, Heng Ni1
1Department of Neurology, Affiliated Hangzhou First People's Hospital Westlake University School of Medicine Hangzhou China.
这项研究将静脉注射蒂罗菲班与标准血栓溶解进行比较,作为急性缺血性中风的内血管血栓切除术 (EVT) 的桥梁. 它调查了罗非班是否是EVT手术中用于大血管封闭的血栓溶解的可行替代品.
科学领域:
- 神经学 神经学
- 心脏病学 心脏病学
- 临床试验 临床试验
背景情况:
- 静脉内血栓切除术 (EVT) 与静脉内血栓溶解是从大血管封闭引起的急性缺血性中风的标准.
- 糖蛋白IIb/IIIa抑制剂,如蒂罗菲班,正在探索用于血栓形成的管理.
- 作为EVT前血栓溶解的替代品,蒂罗菲班的疗效尚未得到充分证实.
研究的目的:
- 评估静脉罗非班加EVT是否不劣于静脉血栓溶解与EVT之间的桥梁.
- 评估提罗菲班作为一种替代辅助治疗在急性缺血性中风患者有资格进行血栓溶解.
主要方法:
- 该ADJUVANT试验是一个多中心的,随机的,开放的,非劣势性研究.
- 976名具有大血管封闭性的血栓溶解合格中风患者将被随机分为2:1.
- 参与者要么接受静脉罗非班+EVT,要么接受静脉血解+EVT.
主要成果:
- 主要疗效结局是90天后的功能独立性 (修改的兰金尺度0-2).
- 关键的安全结果包括症状性内出血和90天死亡率.
结论:
- 在ADJUVANT试验将提供关键的数据,对tirofiban的有效性和安全性.
- 这些发现将为接受EVT的急性缺血性中风患者的治疗策略提供信息.
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