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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04071613




Registration number
NCT04071613
Ethics application status
Date submitted
25/08/2019
Date registered
28/08/2019
Date last updated
8/12/2021

Titles & IDs
Public title
Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
Scientific title
Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
Secondary ID [1] 0 0
2018.043
Universal Trial Number (UTN)
Trial acronym
TASTEa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke, Acute, Stroke Ischemic 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase
Treatment: Drugs - Intravenous tissue plasminogen activator (tPA)

Active Comparator: Intravenous tenecteplase (TNK) - Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).

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.


Treatment: Drugs: Tenecteplase
Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Perfusion lesion on CTP
Timepoint [1] 0 0
Within 2hrs of treatment
Secondary outcome [1] 0 0
Infarct core growth between baseline CTP and 24 hour MRI.
Timepoint [1] 0 0
24 hrs
Secondary outcome [2] 0 0
Percent reperfusion between baseline CTP and 24 hour perfusion imaging (MRI)
Timepoint [2] 0 0
24 hrs
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
2 hrs
Secondary outcome [4] 0 0
Reduction in NIHSS between pre-treatment score and score at 24 hours post treatment, adjusted for pre-treatment NIHSS
Timepoint [4] 0 0
24 hrs
Secondary outcome [5] 0 0
Modified Rankin Scale (mRS) at 3 months - ordinal analysis adjusted for baseline NIHSS and age
Timepoint [5] 0 0
3 months
Secondary outcome [6] 0 0
mRS 0-2 or no change from baseline at 3 months adjusted for baseline NIHSS and age
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Proportion of patients where thrombolytic medication is initiated within 5 minutes of completion of CT on the MSU.
Timepoint [7] 0 0
24 hrs
Secondary outcome [8] 0 0
Time from completion of CT on the MSU to initiation of thrombolysis (CT to needle time)
Timepoint [8] 0 0
2 hrs
Secondary outcome [9] 0 0
mRS 5-6 at 3 months adjusted for baseline NIHSS and age
Timepoint [9] 0 0
3 months
Secondary outcome [10] 0 0
Death due to any cause adjusted for baseline NIHSS and age
Timepoint [10] 0 0
During time on study up to 3 months
Secondary outcome [11] 0 0
Any parenchymal haematoma
Timepoint [11] 0 0
During time on study up to 3 months
Secondary outcome [12] 0 0
ymptomatic intracranial hemorrhage (sICH)
Timepoint [12] 0 0
During time on study up to 3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2021
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
Eastern Health - Melbourne
Recruitment hospital [3] 0 0
Western Hospital - Melbourne
Recruitment hospital [4] 0 0
Alfred Hopsital - Melbourne
Recruitment hospital [5] 0 0
Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04071613
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04071613