Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
NCT ID: NCT04071613
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2019-06-20
2021-11-16
Brief Summary
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Detailed Description
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Ischemic stroke is a major public health problem, for which effective and accessible drug therapies remain limited. Current management of acute ischemic stroke includes treatment with a solution called alteplase, which dissolves clots in a cerebral artery. The treatment effect of alteplase is much greater if given within 90 minutes of stroke onset.
As a result, there has been a significant push to take stroke care to the patient in the form of the Mobile Stroke Unit (MSU). The MSU is the first designed as a CT-capable ambulance that allows assessment and treatment of stroke patients in the pre-hospital setting. In the proposed research project, we will undertake a clinical trail investigating the effectiveness of a new thrombolytic agent in the MSU, tenecteplase.
Tenecteplase has been shown to be significantly more effective at improving stroke survivor's recovery and opening blocked blood vessels than alteplase in the hospital setting. However, it is unknown if earlier administration of tenecteplase is more effective than early administration of alteplase.
The tested agent, tenecteplase, is cheaper, easier to administer (no time-consuming infusions required) and more practical for an ambulance delivered therapy than the current standard of care alteplase. If tenecteplase results in better clinical outcomes in addition to these practical advantages, there is significant scope for improved patient outcomes and cost savings.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intravenous tenecteplase (TNK)
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \~10 seconds).
Tenecteplase
Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset
Intravenous tissue plasminogen activator (tPA)
Patients will receive intravenous t-PA at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
Intravenous tissue plasminogen activator (tPA)
Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes) Frequency: once only, within 4.5 hours of stroke onset
Interventions
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Tenecteplase
Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset
Intravenous tissue plasminogen activator (tPA)
Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes) Frequency: once only, within 4.5 hours of stroke onset
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient's age is ≥18 years
3. Premorbid mRS \<4
Exclusion Criteria
2. Hypodensity in \>1/3 MCA territory or equivalent proportion of ACA or PCA territory on non-contrast CT on MSU
3. Pre-stroke mRS score of \> 3 (indicating significant previous disability)
4. Any terminal illness such that patient would not be expected to survive more than 1 year
5. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
6. Pregnant women.
7. Rapidly improving symptoms.
18 Years
ALL
No
Sponsors
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Melbourne Health
OTHER
Responsible Party
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Locations
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Royal Melbourne Hospital
Melbourne, Victoria, Australia
Eastern Health
Melbourne, Victoria, Australia
Western Hospital
Melbourne, Victoria, Australia
Alfred Hopsital
Melbourne, , Australia
Monash Health
Melbourne, , Australia
Countries
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References
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Bivard A, Zhao H, Churilov L, Campbell BCV, Coote S, Yassi N, Yan B, Valente M, Sharobeam A, Balabanski AH, Dos Santos A, Ng JL, Yogendrakumar V, Ng F, Langenberg F, Easton D, Warwick A, Mackey E, MacDonald A, Sharma G, Stephenson M, Smith K, Anderson D, Choi P, Thijs V, Ma H, Cloud GC, Wijeratne T, Olenko L, Italiano D, Davis SM, Donnan GA, Parsons MW; TASTE-A collaborators. Comparison of tenecteplase with alteplase for the early treatment of ischaemic stroke in the Melbourne Mobile Stroke Unit (TASTE-A): a phase 2, randomised, open-label trial. Lancet Neurol. 2022 Jun;21(6):520-527. doi: 10.1016/S1474-4422(22)00171-5. Epub 2022 May 4.
Bivard A, Zhao H, Coote S, Campbell B, Churilov L, Yassi N, Yan B, Valente M, Sharobeam A, Balabanski A, Dos Santos A, Ng F, Langenberg F, Stephenson M, Smith K, Bernard S, Thijs V, Cloud G, Choi P, Ma H, Wijeratne T, Chen C, Olenko L, Davis SM, Donnan GA, Parsons M. 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. BMJ Open. 2022 Apr 29;12(4):e056573. doi: 10.1136/bmjopen-2021-056573.
Other Identifiers
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2018.043
Identifier Type: -
Identifier Source: org_study_id