Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.
Am Heart J. 2020 Jul;225:38-43. doi: 10.1016/j.ahj.2020.04.003. Epub 2020 Apr 8.
Previous studies have implied the efficacy and safety of argatroban plus recombinant tissue-type plasminogen activator (r-tPA) in patients with acute ischemic stroke. Further trials are needed to establish convincing conclusions in a large sample size.
Argatroban plus r-tPA for Acute Ischemic Stroke (ARAIS) trial is a multicenter, prospective, randomized, open-label, and blind-end point trial. The trial proposes to randomize 808 patients with acute ischemic stroke National Institutes of Health Stroke Scale (NIHSS score≥ 6 at the time of randomization) within 4.5 hours of symptom onset to receive argatroban (100 μg/kg bolus followed by an infusion of 1.0 μg/kg per minute for 48 hours) plus r-tPA or r-tPA alone. The primary end point is the proportion of patients with an excellent outcome of no clinically significant residual stroke deficits (modified Rankin scale 0-1) at 90 days. Secondary end points include the proportion of patients with a good outcome (modified Rankin scale 0-2) at 90 days, early neurological improvement (NIHSS score ≥2-point decrease) at 48 hours, early neurological deterioration (NIHSS score ≥4-point increase) at 48 hours, decrease in the NIHSS score from baseline to 14 days, and stroke recurrence or other vascular events at 90 days. Safety end points include symptomatic intracerebral hemorrhage, parenchymal hematoma type 2, and major systemic bleeding.
ARAIS trial will evaluate whether argatroban plus r-tPA is superior to r-tPA alone in improving functional outcomes in acute ischemic stroke patients in a large sample population.
先前的研究表明，阿加曲班联合重组组织型纤溶酶原激活剂（r-tPA）治疗急性缺血性脑卒中的疗效和安全性。需要进一步的试验来在大样本量中得出令人信服的结论。
急性缺血性脑卒中阿加曲班联合 r-tPA（ARAIS）试验是一项多中心、前瞻性、随机、开放标签、盲终点试验。该试验拟将 808 例发病 4.5 小时内、美国国立卫生研究院卒中量表（NIHSS 评分≥6 分）的急性缺血性脑卒中患者随机分为阿加曲班组（100μg/kg 推注，随后以 1.0μg/kg/分钟的速度输注 48 小时）联合 r-tPA 或 r-tPA 单药治疗组。主要终点为 90 天时无临床显著残留卒中缺陷（改良 Rankin 量表 0-1）的患者比例。次要终点包括 90 天时良好结局（改良 Rankin 量表 0-2）的患者比例、48 小时时的早期神经功能改善（NIHSS 评分下降≥2 分）、48 小时时的早期神经功能恶化（NIHSS 评分增加≥4 分）、从基线到 14 天 NIHSS 评分的下降以及 90 天时的卒中复发或其他血管事件。安全性终点包括症状性颅内出血、脑实质血肿 2 型和主要全身性出血。
ARAIS 试验将评估阿加曲班联合 r-tPA 是否优于 r-tPA 单药治疗，以改善大样本人群急性缺血性脑卒中患者的功能结局。
