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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 : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Melbourne Health

Tracking Information
First Submitted Date  ICMJE August 25, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date September 24, 2020
Actual Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
Official Title  ICMJE Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
Brief Summary Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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
Primary Purpose: Treatment
Condition  ICMJE Stroke, Acute, Stroke Ischemic
Intervention  ICMJE
  • Drug: Tenecteplase
    Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset
    Other Name: TNK
  • 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
Study Arms  ICMJE
  • Active Comparator: Intravenous tenecteplase (TNK)
    Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).
    Intervention: Drug: Tenecteplase
  • 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.
    Intervention: Drug: Intravenous tissue plasminogen activator (tPA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients being attended by the mobile stroke unit with an acute ischemic stroke eligible for thrombolysis using standard clinical and CT criteria.
  2. Patient's age is ≥18 years
  3. Premorbid mRS <4

Exclusion Criteria:

  1. Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor) identified by CT on the MSU
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Parsons, BMed, PhD 61 3 9342 7000 ext 28448 mark.parsons@mh.org.au
Contact: Amy McDonald 61 3 9342 4407 amy.mcdonald@mh.org.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04071613
Other Study ID Numbers  ICMJE 2018.043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Melbourne Health
Study Sponsor  ICMJE Melbourne Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Melbourne Health
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP