Journal article
The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods
International journal of stroke, Vol.16(7), pp.873-880
12/09/2020
DOI: 10.1177/1747493020978345
PMID: 33297893
Abstract
BACKGROUNDIntravenous 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. AIMThe 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 ESTIMATEA maximum of 1200 randomized subjects to test the superiority of argatroban or eptifibatide to placebo in improving 90-day modified Rankin scores. METHODS AND DESIGNMultiarm 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 OUTCOMESThe primary efficacy outcome is improved modified Rankin score assessed at 90 days post-randomization. DISCUSSIONMultiarm 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.
Details
- Title: Subtitle
- The multiarm optimization of stroke thrombolysis phase 3 acute stroke randomized clinical trial: Rationale and methods
- Creators
- S. Iris Deeds - Univ Cincinnati, Dept Emergency Med, 231 Albert Sabin Way,ML 0769, Cincinnati, OH 45267 USAAndrew Barreto - Univ Texas Hlth Sci Ctr Houston, Dept Neurol, Houston, TX 77030 USAJordan Elm - Med Univ South Carolina, Dept Publ Hlth Sci, Data Coordinat Unit, Charleston, SC 29425 USAColin P Derdeyn - Univ Iowa Hosp & Clin, Dept Radiol, Iowa City, IA 52242 USAScott Berry - Berry Consultants LLC, Austin, TX USAPooja Khatri - Univ Cincinnati, Dept Neurol & Rehabil Med, Cincinnati, OH 45221 USAClaudia Moy - NINDS, Bldg 36,Rm 4D04, Bethesda, MD 20892 USAScott Janis - NINDS, Bldg 36,Rm 4D04, Bethesda, MD 20892 USAJoseph Broderick - Univ Cincinnati, Dept Neurol & Rehabil Med, Cincinnati, OH 45221 USAJames Grotta - Texas Med Ctr, Mem Hermann Hosp, Houston, TX USAOpeolu Adeoye - Univ Cincinnati, Dept Emergency Med, 231 Albert Sabin Way,ML 0769, Cincinnati, OH 45267 USA
- Resource Type
- Journal article
- Publication Details
- International journal of stroke, Vol.16(7), pp.873-880
- DOI
- 10.1177/1747493020978345
- PMID
- 33297893
- NLM abbreviation
- Int J Stroke
- ISSN
- 1747-4930
- eISSN
- 1747-4949
- Grant note
- DOI: 10.13039/100000065, name: National Institute of Neurological Disorders and Stroke, award: 1U01NS100699-01A1
- Language
- English
- Date published
- 12/09/2020
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984070858002771
Metrics
13 Record Views