The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods
| العنوان: | The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods |
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| المؤلفون: | Scott M. Berry, Scott Janis, Colin P. Derdeyn, S Iris Deeds, Andrew D Barreto, Joseph P. Broderick, Claudia S. Moy, James C. Grotta, Opeolu Adeoye, Jordan J. Elm, Pooja Khatri |
| المصدر: | Int J Stroke |
| بيانات النشر: | SAGE Publications, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, Article, Argatroban, Brain Ischemia, law.invention, Fibrinolytic Agents, Randomized controlled trial, law, Internal medicine, medicine, Humans, Multicenter Studies as Topic, Single-Blind Method, Thrombolytic Therapy, Recombinant tissue plasminogen activator, Acute ischemic stroke, Randomized Controlled Trials as Topic, business.industry, Stroke, Clinical trial, Clinical Trials, Phase III as Topic, Neurology, Tissue Plasminogen Activator, Cardiology, Eptifibatide, Stroke thrombolysis, Augment, business, medicine.drug |
| الوصف: | Background 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. Aim 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. Sample size estimate A maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores. Methods and design 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. Study outcomes The primary efficacy outcome is improved modified Rankin score assessed at 90 days post-randomization. Discussion 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. |
| تدمد: | 1747-4949 1747-4930 |
| DOI: | 10.1177/1747493020978345 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::06e0612429a310c0d65da3330e135211 https://doi.org/10.1177/1747493020978345 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....06e0612429a310c0d65da3330e135211 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17474949 17474930 |
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| DOI: | 10.1177/1747493020978345 |