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Acta Neurol. Scand. · Nov 2020
Randomized Controlled Trial Multicenter StudyClinical outcomes and safety profile of Tenecteplase in wake-up stroke.
- Hassan Khan Ahmed, Nicola Logallo, Lars Thomassen, Vojtech Novotny, Sara M Mathisen, and Martin W Kurz.
- Department of Neurology, Stavanger University Hospital, Stavanger, Norway.
- Acta Neurol. Scand. 2020 Nov 1; 142 (5): 475-479.
BackgroundTenecteplase has probably pharmacological and clinical advantages in the treatment of acute ischemic stroke. There are lacking data about safety and efficacy of tenecteplase in wake-up stroke (WUPS).AimsTo investigate safety and efficacy of tenecteplase compared to alteplase in WUPS patients included in NOR-TEST.MethodsWUPS patients in NOR-TEST were included in the study based on DWI-FLAIR mismatch. Included patients randomly assigned (1:1) to receive intravenous tenecteplase 0.4 mg/kg (to a maximum of 40 mg) or alteplase 0.9 mg/kg (to a maximum of 90 mg). Neurological improvement was defined as 1) favorable functional outcome at 90 days modified Rankin Scale (mRS) of 0 or 1 and 2) neurological improvement measured with the National Institutes of Health Stroke Scale (NIHSS) of 4 points within 24 hours as compared to admission NIHSS or NIHSS 0 at 24 hours.ResultsOf 1100 patients from 13 stroke centers included in NOR-TEST, 45 were WUPS patients. Of these, 5 patients were stroke mimics and excluded. Of the remaining 40 patients (3.6%), 24 were treated with alteplase (60%). There was no difference in the number of patients achieving a good clinical outcome (mRS 0-1) in either treatment group. Patients treated with tenecteplase showed a better early neurological improvement (87.5% vs 54.2%, P = 0.027). No ICH was detected on MRI/CT 24-28 hours after thrombolysis.ConclusionsIn WUPS patients treated in NOR-TEST, there was no difference in clinical outcomes at 90 days and no ICH events or deaths were observed in either alteplase- or tenecteplase-treated patients. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT01949948.© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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