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.

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.

• Authors: Andrew Bivard, Henry Zhao, Skye Coote, Bruce Campbell, Leonid Churilov, Nawaf Yassi, Bernard Yan, Michael Valente, Angelos Sharobeam, Anna Balabanski, Angela Dos Santos, Felix Ng, Francesca Langenberg, Michael Stephenson, Karen Smith, Steve Bernard, Vincent Thijs, Geoffrey Cloud, Philip Choi, Henry Ma, Tissa Wijeratne, Chushuang Chen, Liudmyla Olenko, Stephen M Davis, Geoffrey A Donnan, Mark Parsons
• Journal: BMJ open (BMJ Open) Vol. 12 Issue 4 Pg. e056573 (04 29 2022) ISSN: 2044-6055 [Electronic] England
• PMID: 35487712 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Fibrinolytic Agents
• Tissue Plasminogen Activator
• Tenecteplase

Topics

• Ambulances
• Brain Ischemia (drug therapy)
• Clinical Trials, Phase II as Topic
• Fibrinolytic Agents (therapeutic use)
• Humans
• Ischemic Stroke
• Prospective Studies
• Randomized Controlled Trials as Topic
• Stroke (drug therapy)
• Taste
• Tenecteplase (therapeutic use)
• Thrombolytic Therapy
• Tissue Plasminogen Activator (therapeutic use)
• Treatment Outcome