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Thrombolysis With Alteplase at 0.6 mg/kg for Stroke With Unknown Time of Onset: A Randomized Controlled Trial.
Stroke ( IF 8.3 ) Pub Date : 2020-04-06 , DOI: 10.1161/strokeaha.119.028127
Masatoshi Koga 1 , Haruko Yamamoto 2 , Manabu Inoue 1 , Koko Asakura 3 , Junya Aoki 4 , Toshimitsu Hamasaki 3 , Takao Kanzawa 5 , Rei Kondo 6 , Masafumi Ohtaki 7 , Ryo Itabashi 8 , Kenji Kamiyama 9 , Toru Iwama 10 , Taizen Nakase 11, 12 , Yusuke Yakushiji 13 , Shuichi Igarashi 14 , Yoshinari Nagakane 15 , Shunya Takizawa 16 , Yasushi Okada 17 , Ryosuke Doijiri 18 , Akira Tsujino 19 , Yasuhiro Ito 20 , Hideyuki Ohnishi 21 , Takeshi Inoue 22 , Yasushi Takagi 23 , Yasuhiro Hasegawa 24 , Yoshiaki Shiokawa 25 , Nobuyuki Sakai 26 , Masato Osaki 27 , Yoshikazu Uesaka 28 , Shinichi Yoshimura 29 , Takao Urabe 30 , Toshihiro Ueda 31 , Masafumi Ihara 32 , Takanari Kitazono 33 , Makoto Sasaki 34 , Akira Oita 35 , Sohei Yoshimura 1 , Mayumi Fukuda-Doi 1, 3 , Kaori Miwa 1 , Kazumi Kimura 4 , Kazuo Minematsu 1, 36 , Kazunori Toyoda 1 ,
Affiliation  

Background and Purpose- We assessed whether lower-dose alteplase at 0.6 mg/kg is efficacious and safe for acute fluid-attenuated inversion recovery-negative stroke with unknown time of onset. Methods- This was an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients met the standard indication criteria for intravenous thrombolysis other than a time last-known-well >4.5 hours (eg, wake-up stroke). Patients were randomly assigned (1:1) to receive alteplase at 0.6 mg/kg or standard medical treatment if magnetic resonance imaging showed acute ischemic lesion on diffusion-weighted imaging and no marked corresponding hyperintensity on fluid-attenuated inversion recovery. The primary outcome was a favorable outcome (90-day modified Rankin Scale score of 0-1). Results- Following the early stop and positive results of the WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke), this trial was prematurely terminated with 131 of the anticipated 300 patients (55 women; mean age, 74.4±12.2 years). Favorable outcome was comparable between the alteplase group (32/68, 47.1%) and the control group (28/58, 48.3%; relative risk [RR], 0.97 [95% CI, 0.68-1.41]; P=0.892). Symptomatic intracranial hemorrhage within 22 to 36 hours occurred in 1/71 and 0/60 (RR, infinity [95% CI, 0.06 to infinity]; P>0.999), respectively. Death at 90 days occurred in 2/71 and 2/60 (RR, 0.85 [95% CI, 0.06-12.58]; P>0.999), respectively. Conclusions- No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset. The safety of alteplase at 0.6 mg/kg was comparable to that of standard treatment. Early study termination precludes any definitive conclusions. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02002325.

中文翻译:

发作时间未知的卒中患者,以0.6 mg / kg的阿替普酶溶栓:随机对照试验。

背景与目的-我们评估了低剂量阿替普酶0.6 mg / kg是否对未知发作时间的急性液体衰减型反转恢复阴性中风有效且安全。方法-这是研究者发起的,多中心,随机,开放标签,盲点试验。除最后一次已知时间> 4.5小时(例如,中风)外,患者符合静脉溶栓的标准指征标准。如果磁共振成像在弥散加权成像中显示出急性缺血性病变,而在体液衰减后的反转恢复中没有明显的相应高信号,则将患者随机分配(1:1)接受0.6 mg / kg的阿替普酶或标准药物治疗。主要结果是良好的结果(90天改良兰金量表评分为0-1)。结果-在WAKE-UP试验(基于MRI的溶栓治疗在中风后的疗效和安全性)的早期停止和积极结果之后,该试验被300例预期中的131例(55岁;平均年龄, 74.4±12.2年)。阿替普酶组(32 / 68,47.1%)与对照组(28 / 58,48.3%;相对危险度[RR],0.97 [95%CI,0.68-1.41]; P = 0.892)之间的良好结果相当。在22/36小时内出现症状性颅内出血的比例分别为1/71和0/60(RR,无穷大[95%CI,0.06至无穷大; P> 0.999)。90天死亡分别发生于2/71和2/60(RR,0.85 [95%CI,0.06-12.58]; P> 0.999)。结论:在未知发作时间的缺血性卒中患者中,阿替普酶组与对照组之间的良好转归没有差异。0.6 mg / kg的阿替普酶的安全性与标准治疗相当。提前终止研究排除了任何明确的结论。注册网址:https://www.clinicaltrials.gov;唯一标识符:NCT02002325。
更新日期:2020-04-06
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