. 2022 Apr 29;12(4):e056573.

doi: 10.1136/bmjopen-2021-056573.

Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (Mobile Stroke Unit-TASTE-A): protocol for a prospective randomised, open-label, blinded endpoint, phase II superiority trial of tenecteplase versus alteplase for ischaemic stroke patients presenting within 4.5 hours of symptom onset to the mobile stroke unit

Andrew Bivard^{1

2}, Henry Zhao^{3

2}, Skye Coote^{3

2}, Bruce Campbell^{3

2}, Leonid Churilov³, Nawaf Yassi^{3

4}, Bernard Yan^{3

5}, Michael Valente^{3

6}, Angelos Sharobeam^{3

2}, Anna Balabanski^{2

7}, Angela Dos Santos^{2

7}, Felix Ng^{3

6}, Francesca Langenberg³, Michael Stephenson⁶, Karen Smith², Steve Bernard⁶, Vincent Thijs^{8

9}, Geoffrey Cloud¹⁰, Philip Choi¹¹, Henry Ma¹², Tissa Wijeratne¹³, Chushuang Chen³, Liudmyla Olenko³, Stephen M Davis^{3

14}, Geoffrey A Donnan^{3

14}, Mark Parsons^{15

16}

Affiliations

¹ Department of Medicine and Neurology, The University of Melbourne, Melbourne, Victoria, Australia abivard@unimelb.edu.au.
² Research and Evaluation, Ambulance Victoria, Doncaster, Victoria, Australia.
³ Department of Medicine and Neurology, The University of Melbourne, Melbourne, Victoria, Australia.
⁴ The Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia.
⁵ Department of Neurology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.
⁶ Ambulance Victoria, Doncaster, Victoria, Australia.
⁷ Department of Neurology, Monash University, Melbourne, Victoria, Australia.
⁸ Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.
⁹ Stroke Unit, Austin Health, Heidelberg, Victoria, Australia.
¹⁰ Department of Neurology, Alfred Health, Monash University, Melbourne, Victoria, Australia.
¹¹ Department of Neurology, Box Hill Hospital, Box Hill, Victoria, Australia.
¹² Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.
¹³ Department of Neurology, Western Health, Footscray, Victoria, Australia.
¹⁴ Melbourne Brain Centre at Royal Melbourne Hospital, Parkville, Victoria, Australia.
¹⁵ School of Medicine and Public Health, Department of Neurology Liverpool Hospital, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.
¹⁶ Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.

PMID: 35487712
PMCID: PMC9058803
DOI: 10.1136/bmjopen-2021-056573

Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (Mobile Stroke Unit-TASTE-A): protocol for a prospective randomised, open-label, blinded endpoint, phase II superiority trial of tenecteplase versus alteplase for ischaemic stroke patients presenting within 4.5 hours of symptom onset to the mobile stroke unit

Andrew Bivard et al. BMJ Open. 2022.

. 2022 Apr 29;12(4):e056573.

doi: 10.1136/bmjopen-2021-056573.

Authors

Affiliations

¹ Department of Medicine and Neurology, The University of Melbourne, Melbourne, Victoria, Australia abivard@unimelb.edu.au.
² Research and Evaluation, Ambulance Victoria, Doncaster, Victoria, Australia.
³ Department of Medicine and Neurology, The University of Melbourne, Melbourne, Victoria, Australia.
⁴ The Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia.
⁵ Department of Neurology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.
⁶ Ambulance Victoria, Doncaster, Victoria, Australia.
⁷ Department of Neurology, Monash University, Melbourne, Victoria, Australia.
⁸ Florey Institute of Neuroscience and Mental Health - Austin Campus, Heidelberg, Victoria, Australia.
⁹ Stroke Unit, Austin Health, Heidelberg, Victoria, Australia.
¹⁰ Department of Neurology, Alfred Health, Monash University, Melbourne, Victoria, Australia.
¹¹ Department of Neurology, Box Hill Hospital, Box Hill, Victoria, Australia.
¹² Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.
¹³ Department of Neurology, Western Health, Footscray, Victoria, Australia.
¹⁴ Melbourne Brain Centre at Royal Melbourne Hospital, Parkville, Victoria, Australia.
¹⁵ School of Medicine and Public Health, Department of Neurology Liverpool Hospital, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.
¹⁶ Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.

PMID: 35487712
PMCID: PMC9058803
DOI: 10.1136/bmjopen-2021-056573

Abstract

Introduction: Mobile stroke units (MSUs) equipped with a CT scanner are increasingly being used to assess and treat stroke patients' prehospital with thrombolysis and transfer them to the most appropriate hospital for ongoing stroke care and thrombectomy when indicated. The effect of MSUs in both reducing the time to reperfusion treatment and improving patient outcomes is now established. There is now an opportunity to improve the efficacy of treatment provided by the MSU. Tenecteplase is a potent plasminogen activator, which may have benefits over the standard of care stroke lytic alteplase. Specifically, in the MSU environment tenecteplase presents practical benefits since it is given as a single bolus and does not require an infusion over an hour like alteplase.

Objective: In this trial, we seek to investigate if tenecteplase, given to patients with acute ischaemic stroke as diagnosed on the MSU, improves the rate of early reperfusion.

Methods and analysis: TASTE-A is a prospective, randomised, open-label, blinded endpoint (PROBE) phase II trial of patients who had an ischaemic stroke assessed in an MSU within 4.5 hours of symptom onset. The primary endpoint is early reperfusion measured by the post-lysis volume of the CT perfusion lesion performed immediately after hospital arrival.

Ethics and dissemination: The study was approved by the Royal Melbourne Hospital Human Ethics committee. The findings will be published in peer-reviewed journals, presented at academic conferences and disseminated among consumer and healthcare professional audiences.

Trial registration number: NCT04071613.

Keywords: Computed tomography; Neurology; STROKE MEDICINE; Stroke.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Study assessments and procedures. AEs, adverse events; CTA, CT angiography; HT, haemorrhagic transformation; MSU, mobile stroke unit.

See this image and copyright information in PMC

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