INTRAVENOUS THROMBOLYSIS WITH RECOMBINANT TISSUE-PLASMINOGEN ACTIVATOR FOR ACUTE HEMISPHERIC STROKE - THE EUROPEAN COOPERATIVE ACUTE STROKE STUDY (ECASS)
INTRAVENOUS THROMBOLYSIS WITH RECOMBINANT TISSUE-PLASMINOGEN ACTIVATOR FOR ACUTE HEMISPHERIC STROKE - THE EUROPEAN COOPERATIVE ACUTE STROKE STUDY (ECASS)
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DOI：
10.1001/jama.274.13.1017
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发表时间：
1995-10-04
影响因子：
120.7
通讯作者：
HENNERICI, M
中科院分区：
文献类型：
--
作者：
HACKE, W;KASTE, M;HENNERICI, M
客观。-评价重组组织型纤溶酶原激活剂（rt-PA）静脉溶栓治疗急性缺血性卒中的疗效和安全性。随机、前瞻性、多中心、双盲、安慰剂对照临床试验。共有75家医院在14个欧洲国家。共有620例急性缺血性半球卒中和中度至重度神经功能缺损患者，在初始计算机断层扫描（CT）上没有主要的早期梗死体征。患者在症状发作后6小时内随机接受rt-PA（阿替普酶）或安慰剂治疗，剂量为1.1 mg/kg体重。主要终点包括90天时的Barthel指数（BI）和改良兰金量表（RS）。次要终点包括合并BI和RS、90天时的斯堪的纳维亚卒中量表（SSS）和30天时的死亡率。三级终点包括早期神经功能恢复（SSS）和住院时间。安全性参数包括死亡率和颅内或颅外损伤的发生率。在意向治疗（ITT）分析和目标人群（TP）解释性分析中，rt-PA和安慰剂治疗组患者的人口统计学变量分布相似。共有109例患者（17.4%）入选试验，尽管存在重大方案违背，但从TP中排除。ITT分析中的主要终点无差异，而TP分析显示RS存在显著差异，有利于rt-PA治疗患者（P= 0.035）。在次要终点中，两项分析中BI和RS的组合均显示出有利于rt-PA治疗患者的差异（P
Objective.-To evaluate the efficacy and safety of intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) in patients with acute ischemic stroke.Design.-Randomized, prospective, multicenter, double-blind, placebo-controlled clinical trial.Setting.-A total of 75 hospitals in 14 European countries.Patients.-A total of 620 patients with acute ischemic hemispheric stroke and moderate to severe neurologic deficit and without major early infarct signs on initial computed tomography (CT).Intervention.-Patients were randomized to treatment with 1.1 mg per kilogram of body weight of rt-PA (alteplase) or placebo within 6 hours from the onset of symptoms.Outcome Measures.-Primary end points included Barthel Index (BI) and modified Rankin Scale (RS) at 90 days. Secondary end points included combined BI and RS, Scandinavian Stroke Scale (SSS) at 90 days, and 30-day mortality. Tertiary end points included early neurologic recovery (SSS) and duration of in-hospital stay. Safety parameters included mortality and incidence of intracranial or extracranial hemorrhage.Results.-The distribution of demographic variables was similar among patients in the rt-PA and placebo treatment arms in both the intention-to-treat (ITT) analysis and the explanatory analysis for the target population (TP). A total of 109 patients (17.4%) were included in the trial despite major protocol violations but excluded from the TP. There was no difference in the primary end points in the ITT analysis, while the TP analysis revealed a significant difference in the RS in favor of rt-PA-treated patients (P=.035). Of the secondary end points, the combined BI and RS showed a difference in favor of rt-PA-treated patients in both analyses (P