The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods.
The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods.
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DOI：
10.1177/1747493020978345
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发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
Adeoye O
中科院分区：
文献类型：
--
作者：
Deeds SI;Barreto A;Elm J;Derdeyn CP;Berry S;Khatri P;Moy C;Janis S;Broderick J;Grotta J;Adeoye O
静脉注射重组组织纤溶酶原激活剂是唯一被证明有效治疗急性缺血性中风的药物。可以增强重组组织纤溶酶原激活物溶栓并预防动脉再闭塞的两种方法是用阿加曲班直接抑制凝血酶和用依替巴肽抑制糖蛋白2b/3a受体。中风溶栓试验的多组优化旨在确定在症状出现 3 小时内接受静脉注射重组组织纤溶酶原激活剂治疗的急性缺血性中风患者中，与安慰剂相比，静脉注射阿加曲班或依替巴肽的安全性和有效性。最多 1200 名随机受试者测试阿加曲班或依替巴肽在改善 90 天改良 Rankin 评分方面相对于安慰剂的优越性。卒中溶栓的多臂优化是在美国国立卫生研究院 StrokeNet 临床试验网络内进行的一项多中心、多臂、适应性、单盲、随机对照 3 期临床试验。卒中症状发作 3 小时内接受 0.9 mg/kg 静脉注射重组组织纤溶酶原激活剂治疗的患者随机接受静脉阿加曲班（100 μg/kg 推注，然后 3 μg/kg/min，持续 12 小时）、静脉依替巴肽（135 μg/kg 推注，然后 0.75 μg/kg/min 输注，持续 2 小时）或静脉注射安慰剂。患者可以按照常规护理接受血管内血栓切除术。主要疗效结果是随机化后 90 天评估的改良 Rankin 评分的改善。中风溶栓的多臂优化是一个创新的协作项目，是多年来为改善中风患者的预后而付出的努力的结晶。
Intravenous recombinant tissue plasminogen activator is the only proven effective medication for the treatment of acute ischemic stroke. Two approaches that may augment recombinant tissue plasminogen activator thrombolysis and prevent arterial reocclusion are direct thrombin inhibition with argatroban and inhibition of the glycoprotein 2b/3a receptor with eptifibatide. The multi-arm optimization of stroke thrombolysis trial aims to determine the safety and efficacy of intravenous therapy with argatroban or eptifibatide as compared with placebo in acute ischemic stroke patients treated with intravenous recombinant tissue plasminogen activator within 3 h of symptom onset. A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores. Multiarm optimization of stroke thrombolysis is a multicenter, multiarm, adaptive, single blind, randomized controlled phase 3 clinical trial conducted within the National Institutes of Health StrokeNet clinical trial network. Patients treated with 0.9 mg/kg intravenous recombinant tissue plasminogen activator within 3 h of stroke symptom onset are randomized to receive intravenous argatroban (100 μg/kg bolus followed by 3 μg/kg/min for 12 h), intravenous eptifibatide (135 μg/kg bolus followed by 0.75 μg/kg/min infusion for 2 h) or IV placebo. Patients may receive endovascular thrombectomy per usual care. The primary efficacy outcome is improved modified Rankin score assessed at 90 days postrandomization. Multiarm optimization of stroke thrombolysis is an innovative and collaborative project that is the culmination of many years of dedicated efforts to improve outcomes for stroke patients.
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影响因子：
8.3
作者：
Chaisinanunkul N;Adeoye O;Lewis RJ;Grotta JC;Broderick J;Jovin TG;Nogueira RG;Elm JJ;Graves T;Berry S;Lees KR;Barreto AD;Saver JL;DAWN Trial and MOST Trial Steering Committees;Additional contributors from DAWN Trial Steering Committee
通讯作者：
Additional contributors from DAWN Trial Steering Committee
影响因子：
8.3
作者：
Adeoye, Opeolu;Sucharew, Heidi;Pancioli, Arthur M.
通讯作者：
Pancioli, Arthur M.
影响因子：
8.3
作者：
Mori, Etsuro;Minematsu, Kazuo;Hirano, Teruyuki
通讯作者：
Hirano, Teruyuki
影响因子：
158.5
作者：
Berkhemer, O. A.;Fransen, P. S. S.;Dippel, D. W. J.
通讯作者：
Dippel, D. W. J.
影响因子：
8.3
作者：
Barreto AD;Ford GA;Shen L;Pedroza C;Tyson J;Cai C;Rahbar MH;Grotta JC;ARTSS-2 Investigators
通讯作者：
ARTSS-2 Investigators