Academic Journal
A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke with Proven Occlusion (TEMPO-2): Rational and design of a multicenter, randomized open-label clinical trial
| Title: | A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke with Proven Occlusion (TEMPO-2): Rational and design of a multicenter, randomized open-label clinical trial |
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| Authors: | Nishita Singh, Carol C Kenney, Ken S Butcher, Brian Buck, Philip A Barber, Thalia S Field, Philip M Choi, Amy YX Yu, Timothy Kleinig, Ramana Appireddy, Carlos A Molina, Keith W Muir, Michael D Hill, Shelagh B Coutts |
| Contributors: | Institut Català de la Salut, [Singh N] Neurology Division, Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada. [Kenney CC, Barber PA] Departments of Neurosciences, Radiology and Community Health Sciences, University of Calgary, Calgary, AB, Canada. [Butcher KS] School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia. [Buck B] Division of Neurology, Department of Medicine, University of Alberta, Edmonton, AB, Canada. [FieldTS] Vancouver Stroke Program, Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada. [Molina CA] Unitat d’Ictus, Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Source: | Int J Stroke Scientia Scientia. Dipòsit d'Informació Digital del Departament de Salut instname |
| Publisher Information: | SAGE Publications, 2024. |
| Publication Year: | 2024 |
| Subject Terms: | Male, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Malalties cerebrovasculars - Tractament, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Administration Routes::Administration, Intravenous, Teràpia intravenosa, 03 medical and health sciences, 0302 clinical medicine, Fibrinolytic Agents, DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Stroke, Humans, Multicenter Studies as Topic, Prospective Studies, Aged, Ischemic Stroke, Randomized Controlled Trials as Topic, Other subheadings::Other subheadings::Other subheadings::/drug therapy, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::vías de administración de medicamentos::administración intravenosa, Standard of Care, Middle Aged, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::tratamiento trombolítico, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Thrombolytic Therapy, ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::accidente cerebrovascular, Treatment Outcome, Tissue Plasminogen Activator, Tenecteplase, Female, Teràpia trombolítica, Protocols |
| Description: | Background: Almost half of acute ischemic stroke patients present with mild symptoms and there are large practice variations in their treatment globally. Individuals with an intracranial occlusion who present with minor stroke are at an increased risk of early neurological deterioration and poor outcomes. Individual patient data meta-analysis in the subgroup of patients with minor deficits showed benefit of alteplase in improving outcomes; however, this benefit has not been seen with intravenous alteplase in published randomized trials. Design: TEMPO-2 (A Randomized Controlled Trial of Tenecteplase Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion) is a prospective, open label with blinded outcome assessment, randomized controlled trial, designed to test the superiority of intravenous tenecteplase (0.25 mg/kg) over nonthrombolytic standard of care, with an estimated sample size of 1274 patients. Adult patients presenting with acute ischemic stroke with the National Institutes of Health Stroke Scale (NIHSS) ⩽ 5 and visible arterial occlusion or perfusion deficit within 12 h of onset are randomized to receive either tenecteplase (0.25 mg/kg) or standard of care. The primary outcome is return to baseline neurological functioning, measured by the modified Rankin scale (mRS) at 90 days. Safety outcomes include death and symptomatic hemorrhage (intra or extra-cranial). Other secondary outcomes include mRS 0–1, mRS 0–2, ordinal shift analysis of the mRS, partial, and full recanalization on follow-up computed tomography angiogram. Conclusion: Results of this trial will aid in determining whether there is benefit of using tenecteplase (0.25 mg/kg) in treating patients presenting with minor stroke who are at high risk of developing poor outcomes due to presence of an intracranial occlusion. Data access statement: Data will be available upon reasonable request. |
| Document Type: | Article Other literature type |
| File Description: | application/pdf |
| Language: | English |
| ISSN: | 1747-4949 1747-4930 |
| DOI: | 10.1177/17474930241253702 |
| Access URL: | https://pubmed.ncbi.nlm.nih.gov/38676572 https://hdl.handle.net/11351/12113 |
| Rights: | CC BY NC URL: http://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://us.sagepub.com/en-us/nam/open-access-at-sage). |
| Accession Number: | edsair.doi.dedup.....a711410794c66ab39a9e9d08f877c10c |
| Database: | OpenAIRE |
| ISSN: | 17474949 17474930 |
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| DOI: | 10.1177/17474930241253702 |