Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (TASTEa)
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|ClinicalTrials.gov Identifier: NCT04071613|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute, Stroke Ischemic||Drug: Tenecteplase Drug: Intravenous tissue plasminogen activator (tPA)||Phase 2|
Currently, alteplase is the standard clot-dissolving therapy for ischemic stroke, however this treatment is only effective in 30-45% of patients. Importantly, treatment of ischemic stroke is more effective when given within 90 minutes of stroke onset. Means of treating patients earlier with more effective therapies are needed.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicentre, prospective, randomised open-label blinded endpoint (PROBE) phase II study in stroke thrombolysis patients to compare tenecteplase and alteplase for an outcome of less disability at 3 months|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The people assessing the outcomes The people analysing the results/data|
|Official Title:||Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Active Comparator: Intravenous tenecteplase (TNK)
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).
Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset
Other Name: TNK
Active Comparator: 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.
Drug: 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 Name: TPA, Alteplase
- Perfusion lesion on CTP [ Time Frame: Within 2hrs of treatment ]The volume of the perfusion lesion on CTP performed on arrival at the receiving hospital, adjusted for pre-treatment NIHSS and time from initiation of treatment to CTP.
- Infarct core growth between baseline CTP and 24 hour MRI. [ Time Frame: 24 hrs ]
- Percent reperfusion between baseline CTP and 24 hour perfusion imaging (MRI) [ Time Frame: 24 hrs ]
- Reduction in NIHSS between pre-treatment score and score on ED arrival, adjusted for pre-treatment NIHSS and time from initiation of treatment to ED NIHSS score [ Time Frame: 2 hrs ]
- Reduction in NIHSS between pre-treatment score and score at 24 hours post treatment, adjusted for pre-treatment NIHSS [ Time Frame: 24 hrs ]
- Modified Rankin Scale (mRS) at 3 months - ordinal analysis adjusted for baseline NIHSS and age [ Time Frame: 3 months ]
- mRS 0-2 or no change from baseline at 3 months adjusted for baseline NIHSS and age [ Time Frame: 3 months ]
- Proportion of patients where thrombolytic medication is initiated within 5 minutes of completion of CT on the MSU. [ Time Frame: 24 hrs ]
- Time from completion of CT on the MSU to initiation of thrombolysis (CT to needle time) [ Time Frame: 2 hrs ]
- mRS 5-6 at 3 months adjusted for baseline NIHSS and age [ Time Frame: 3 months ]
- Death due to any cause adjusted for baseline NIHSS and age [ Time Frame: During time on study up to 3 months ]
- Any parenchymal haematoma [ Time Frame: During time on study up to 3 months ]
- ymptomatic intracranial hemorrhage (sICH) [ Time Frame: During time on study up to 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071613
|Contact: Mark Parsons, BMed, PhD||61 3 9342 7000 ext email@example.com|
|Contact: Amy McDonald||61 3 9342 firstname.lastname@example.org|
|Royal Melbourne Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3050|
|Contact: Amy McDonald 393424424 email@example.com|