Interventional Management of Stroke Study

静脉注射重组组织型纤溶酶原激活剂是治疗急性脑缺血的有效方法 中风，但单独用于开放主要的颅外和颅内闭塞时有很大的局限性 动脉。EMS和IMS I试点研究(有120多名受试者)，以及来自不同领域的临床系列 中心的研究表明，静脉(IV)和动脉(IA)相结合的再通方法， 在发病后三小时内使用rt-PA，与使用rt-PA一样安全，并可能提高疗效 与NINDS RT-PA卒中试验期间使用的全量静脉注射rt-PA相比。干预性的 卒中管理(IMS)III试验是一项随机、开放标签的多中心研究，最多 900例急性缺血性卒中患者在发病3小时内可接受静脉注射rt-PA 发病且基线NIH卒中量表评分(NIHSSS)等于或大于10。 IMS III试验的目标是确定缺血性中风患者是否接受rt-PA治疗，利用联合 IV/IA途径在发病3小时内开始再通，更有可能有有利的 与单纯接受标准静脉注射rt-PA的受试者相比，3个月后的结果(Rankin 0-2)。这个 安全性的主要指标将是3个月内的死亡率和有症状的脑出血 从随机化开始的前36小时。除了其他临床和成像终端，经济影响 将对IV/IA疗法的有效性进行评估。这项研究将使用分层随机方法，在这些研究中，有 NIHSSS为10-19的基线将按1：1的比例随机分配，患有NIHSSS&GT；20的受试者将 随机化成2：1的比例，IV/IA组的比例更高。将对以下项目进行主要分组分析 有NIHSS&>20分的第二组受试者。这项试验是开放标签的，因为 不可能进行干预，但3个月主端点和次要端点将由 调查员对治疗任务视而不见。

Intravenous recombinant tissue plasminogen activator (IV rt-PA) is an effective therapy for acute ischemic stroke but has substantial limitations when used alone to open occluded major extracranial and intracranial arteries. The EMS and IMS I Pilot Studies (with over 120 subjects), as well clinical series from various centers, demonstrate that a combined intravenous (IV) and intra-arterial (IA) approach to recanalization, using rt-PA administered within three hours of onset, is as safe and may have improved efficacy as compared to full-dose IV rt-PA as administered during the NINDS rt-PA Stroke Trial. The Interventional Management of Stroke (IMS) III Trial is a randomized, open-label, multi-center study with a maximum of 900 subjects with acute ischemic stroke who are eligible to receive IV rt-PA within 3 hours of symptom onset and whose baseline NIH Stroke Scale score (NIHSSS) is equal to or greater than 10. The primary goal of the IMS III Trial is to determine if ischemic stroke subjects treated with rt-PA, utilizing a combined IV/IA approach to recanalization started within 3 hours of onset, are more likely to have a favorable outcome at 3 months (Rankin 0-2) as compared to subjects treated with standard IV rt-PA alone. The primary measures of safety will be mortality at 3 months and the presence of symptomatic ICH within the first 36 hours from randomization. In addition to other clinical and imaging endpoints, the economic impact of the IV/IA therapy will be evaluated. The study will use stratified randomization in which subjects with a baseline NIHSSS of 10-19 will be randomized in a 1:1 ratio and subjects with NIHSSS >20 will be randomized to a 2:1 ratio with more in the IV/IA group. A primary subgroup analysis will be conducted on the second stratum of subjects with an NIHSS > 20. The trial is open-label since blinding of the intervention is not possible but the primary 3-month and secondary endpoints will be done by an investigator blinded to treatment assignment.