LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000243718
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
28/02/2013
Date last updated
17/08/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial
Query!
Scientific title
Multicentre, prospective, randomised open-label blinded endpoint (PROBE) phase III study in stroke thrombolysis patients to compare tenecteplase and alteplase for an outcome of less disability at 3 months.
Query!
Secondary ID [1]
281969
0
HMRI2012101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TASTE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute ischaemic stroke
288396
0
Query!
Condition category
Condition code
Stroke
288742
288742
0
0
Query!
Ischaemic
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Tenecteplase (TNK)
Dose: 0.25 mg/kg
Route: IV bolus injection
Frequency: once only, within 4.5 hours of stroke onset
Query!
Intervention code [1]
286536
0
Treatment: Drugs
Query!
Comparator / control treatment
Alteplase (tPA)
Dose: 0.9 mg/kg
Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes)
Frequency: once only, within 4.5 hours of stroke onset
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
288884
0
Modified Rankin Scale (mRS) 0-1 at 3 months (no disability).
Query!
Timepoint [1]
288884
0
3 months
Query!
Secondary outcome [1]
301233
0
Reperfusion at 24 hours post stroke. All patients will have a CT or MRI at 24 hours post treatment to assess for reperfusion.
Query!
Timepoint [1]
301233
0
24 hours post stroke
Query!
Secondary outcome [2]
301235
0
Early clinical improvement (reduction in acute – 24 hour NIHSS score)
Query!
Timepoint [2]
301235
0
24 hours post stroke
Query!
Secondary outcome [3]
301237
0
Modified Rankin Scale (mRS) 0-1 at 3 months (adjusted for baseline age and NIHSS)
Query!
Timepoint [3]
301237
0
3 months
Query!
Secondary outcome [4]
301238
0
Modified Rankin Scale 0-2
Query!
Timepoint [4]
301238
0
3 months
Query!
Secondary outcome [5]
301239
0
Categorical shift in mRS
Query!
Timepoint [5]
301239
0
3 months
Query!
Secondary outcome [6]
301240
0
Infarct growth. All patients will have CT or MRI at 24 hours post treatment to assess for infarct growth.
Query!
Timepoint [6]
301240
0
24 hours
Query!
Secondary outcome [7]
301241
0
Recanalisation. All patients will have CT or MRI at 24 hours post treatment to assess for recanalisation.
Query!
Timepoint [7]
301241
0
24 hours post stroke
Query!
Secondary outcome [8]
301242
0
Symptomatic intra-cerebral haemorrhage (sICH). All patients will have CT or MRI at 24 hours post treatment to assess for ICH.
Query!
Timepoint [8]
301242
0
During time on study (3 months)
Query!
Secondary outcome [9]
301243
0
Death due to any cause
Query!
Timepoint [9]
301243
0
During time on study (3 months)
Query!
Secondary outcome [10]
301244
0
Modified Rankin Scale (mRS) 5-6 (severe disability or death).
Query!
Timepoint [10]
301244
0
3 months
Query!
Eligibility
Key inclusion criteria
1. Patients presenting with acute hemispheric ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset.
2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
Imaging inclusion criteria:
1. Presence of penumbra - Using CTP or perfusion MR mismatch between the Tmax > 6 seconds delay perfusion volume and CTP relative cerebral blood flow (relCBF) or diffusion MR lesion infarct core volume
a) Mismatch ratio between Tmax perfusion lesion volume and infarct core lesion volume of > 1.8
b) Penumbra volume > 15 mL (Tmax lesion volume –infarct core lesion volume), and
2. Infarct core lesion volume < 70 mL. Note minimum slice coverage required for CTP will be 80 mm to prevent underestimation of infarct core volume with this modality.
3. Volume of severely hypoperfused tissue < 100mL (Tmax > 10 seconds delay or Delay Time > 8 seconds) indicative of poor response to reperfusion.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Gender
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Intracranial haemorrhage (ICH) identified by CT or MRI.
2. Rapidly improving symptoms at the discretion of the investigator.
3. Pre-stroke mRS score of greater than or equal to 2 (indicating previous disability).
4. Participation in any investigational study in the previous 30 days.
5. Any terminal illness such that patient would not be expected to survive more than 1 year.
6. 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.
7. Pregnant women.
8. Previous stroke within last three months.
9. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
10. Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (INR > 1.5).
11. Current use of novel oral anticoagulants (NOACs) (i.e. dabigatran, rivaroxaban, or apixiban).
12. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
13. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or or low-dose aspirin) prior to study entry is permitted.
14. Clinically significant hypoglycaemia.
15. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or > 110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of “aggressive treatment” is left to the discretion of the responsible Investigator.
16. Hereditary or acquired haemorrhagic diathesis.
17. Gastrointestinal or urinary bleeding within the preceding 21 days.
18. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
19. Exposure to a thrombolytic agent within the previous 72 hours.
20. An extracranial or intracranial internal carotid artery occlusion or a proximal M1 middle cerebral artery occlusion which, in the judgment of the investigator, would be more appropriately treated with combined intravenous intra-arterial therapy, where the intra-arterial therapy can be accessed and delivered within a rapid time frame.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy will be approached by a member of the research team and provided with a PIS/ICF. If consent is obtained, an online randomisation will occur and a treatment arm allocated. Allocation is not concealed.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation design will be used with stratifications for the size of baseline infarct core (less than or greater than 25 mL), and for the presence or absence of ICA occlusion.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Multicentre, prospective, randomised open-label blinded endpoint (PROBE) phase III study.
Patients will be randomised 1:1 to standard dose tPA (0.9 mg/kg) or TNK (0.25 mg/kg). There will be two randomisation strata: first, randomisation will be stratified by the presence or absence of internal carotid artery occlusion (ICAO) on baseline CT or MR angiography; second, randomisation will be stratified by size of infarct core (above or below 25 mL) on baseline CTP or diffusion-weighted MRI (DWI). Patients with ICAO will be capped at a maximum of 25% of the sample size.
Query!
Phase
Phase 3
Query!
Type of endpoint(s)
Safety/efficacy
Query!
Statistical methods / analysis
The primary efficacy analyses will be based on an intention-to-treat basis. The primary outcome will be compared using a two-sided significance test with alpha set at p = 0.05 (unadjusted).
For the secondary outcomes analysis, the proportions of mRS 0-1 outcomes will be compared between TNK and tPA arms adjusted for age and baseline NIHSS score using a binary logistic regression model. Analysis of the categorical shift in mRS will also be undertaken on the full range (0-6) of the mRS using Cochran-Mantel-Haenszel shift test and proportional odds logistic regression subject to the validity of shift analysis model assumptions. Other secondary outcome analyses will be carried out according to standard statistical principles for comparison of parametric or non-parametric distributions as appropriate.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/05/2013
Query!
Actual
21/03/2014
Query!
Date of last participant enrolment
Anticipated
31/07/2018
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
1024
Query!
Accrual to date
186
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
600
0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Query!
Recruitment hospital [2]
601
0
Gosford Hospital - Gosford
Query!
Recruitment hospital [3]
643
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [4]
646
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [5]
647
0
Royal Brisbane & Womens Hospital - Herston
Query!
Recruitment hospital [6]
649
0
Gold Coast Hospital - Southport
Query!
Recruitment hospital [7]
650
0
Royal Melbourne Hospital - City campus - Parkville
Query!
Recruitment hospital [8]
651
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [9]
654
0
Monash Medical Centre - Clayton campus - Clayton
Query!
Recruitment hospital [10]
655
0
The Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [11]
2327
0
Barwon Health - Geelong Hospital campus - Geelong
Query!
Recruitment hospital [12]
8824
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [13]
8825
0
Sunshine Hospital - St Albans
Query!
Recruitment hospital [14]
8826
0
Calvary Public Hospital ACT - Bruce
Query!
Recruitment postcode(s) [1]
6378
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
6382
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
6376
0
2250 - Gosford
Query!
Recruitment postcode(s) [4]
6394
0
2305 - New Lambton Heights
Query!
Recruitment postcode(s) [5]
16950
0
2617 - Bruce
Query!
Recruitment postcode(s) [6]
16949
0
3021 - St Albans
Query!
Recruitment postcode(s) [7]
6386
0
3052 - Parkville
Query!
Recruitment postcode(s) [8]
6387
0
3128 - Box Hill
Query!
Recruitment postcode(s) [9]
6390
0
3168 - Clayton
Query!
Recruitment postcode(s) [10]
8002
0
3220 - Geelong
Query!
Recruitment postcode(s) [11]
6383
0
4006 - Herston
Query!
Recruitment postcode(s) [12]
6385
0
4215 - Southport
Query!
Recruitment postcode(s) [13]
16948
0
4575 - Birtinya
Query!
Recruitment postcode(s) [14]
6391
0
5000 - Adelaide
Query!
Recruitment outside Australia
Country [1]
6895
0
Taiwan, Province Of China
Query!
State/province [1]
6895
0
Query!
Country [2]
6896
0
Canada
Query!
State/province [2]
6896
0
Alberta
Query!
Country [3]
8111
0
United Kingdom
Query!
State/province [3]
8111
0
England
Query!
Country [4]
8112
0
Spain
Query!
State/province [4]
8112
0
Barcelona
Query!
Country [5]
9153
0
Belgium
Query!
State/province [5]
9153
0
Flemish Brabant
Query!
Country [6]
9154
0
New Zealand
Query!
State/province [6]
9154
0
Christchurch
Query!
Funding & Sponsors
Funding source category [1]
286785
0
Government body
Query!
Name [1]
286785
0
National Health and Medical Research Council (NHMRC)
Query!
Address [1]
286785
0
GPO Box 1421
Canberra ACT 2601
Query!
Country [1]
286785
0
Australia
Query!
Funding source category [2]
289090
0
Charities/Societies/Foundations
Query!
Name [2]
289090
0
Greater Charitable Foundation
Query!
Address [2]
289090
0
PO Box 173
Hamilton NSW 2303
Query!
Country [2]
289090
0
Australia
Query!
Funding source category [3]
289091
0
Charities/Societies/Foundations
Query!
Name [3]
289091
0
National Heart Foundation of Australia
Query!
Address [3]
289091
0
Unit 1,
Level 1,
17-23 Townshend St,
Phillip ACT 2606
Query!
Country [3]
289091
0
Australia
Query!
Primary sponsor type
Other Collaborative groups
Query!
Name
Acute Stroke Service
Query!
Address
Department of Neurology
John Hunter Hospital
Locked Bag 1
HRMC NSW 2310
Query!
Country
Australia
Query!
Secondary sponsor category [1]
285568
0
University
Query!
Name [1]
285568
0
The University of Newcastle
Query!
Address [1]
285568
0
University Drive
Callaghan NSW 2308
Query!
Country [1]
285568
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
288852
0
Hunter New England Human Research Ethics Committee
Query!
Ethics committee address [1]
288852
0
Locked Bag 1
New Lambton NSW 2305
Query!
Ethics committee country [1]
288852
0
Australia
Query!
Date submitted for ethics approval [1]
288852
0
31/01/2013
Query!
Approval date [1]
288852
0
11/04/2013
Query!
Ethics approval number [1]
288852
0
HREC/13/HNE/23
Query!
Ethics committee name [2]
290877
0
Human Research Ethics Committee (TQEH/LMH/MH)
Query!
Ethics committee address [2]
290877
0
Basil Hetzel Institute DX465101
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Query!
Ethics committee country [2]
290877
0
Australia
Query!
Date submitted for ethics approval [2]
290877
0
Query!
Approval date [2]
290877
0
02/04/2014
Query!
Ethics approval number [2]
290877
0
HREC/13/TQEHLMH/303
Query!
Summary
Brief summary
This research is comparing two clot dissolving medications tenecteplase and alteplase. Tenecteplase is not currently licensed and approved for use in acute stroke care, but has shown very promising results in recent stroke studies. Alteplase is the approved medication for ischaemic stroke. Despite the clear benefits of alteplase at reducing brain damage and disability, we would like to find a medication that has similar clot-dissolving effects with a lower risk of brain bleeding. This would result in an even greater reduction in long-term stroke disability.
The aim of this study is to compare alteplase with tenecteplase for stroke treatment to determine which will help more patients have less disability at 3 months following their stroke.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Attachments [1]
30
30
0
0
/AnzctrAttachments/363714-TASTE Lead HREC Approval letter 110413.pdf
Query!
Query!
Attachments [2]
31
31
0
0
/AnzctrAttachments/363714-HREC13TQEHLMH303Approval.pdf
Query!
Query!
Contacts
Principal investigator
Name
37914
0
Prof Neil Spratt
Query!
Address
37914
0
Department of Neurology
John Hunter Hospital
Locked Bag 1
HRMC NSW 2310
Query!
Country
37914
0
Australia
Query!
Phone
37914
0
61 2 4921 3490
Query!
Fax
37914
0
Query!
Email
37914
0
neil.spratt@hnehealth.nsw.gov.au
Query!
Contact person for public queries
Name
37915
0
Ms Michelle Russell
Query!
Address
37915
0
Department of Neurology
John Hunter Hospital
Locked Bag 1
HRMC NSW 2310
Query!
Country
37915
0
Australia
Query!
Phone
37915
0
+61 2 4921 3450
Query!
Fax
37915
0
+61 2 4921 3488
Query!
Email
37915
0
michelle.russell@hnehealth.nsw.gov.au
Query!
Contact person for scientific queries
Name
37916
0
Prof Chris Levi
Query!
Address
37916
0
Department of Neurology
John Hunter Hospital
Locked Bag 1
HRMC NSW 2310
Query!
Country
37916
0
Australia
Query!
Phone
37916
0
+61 2 4921 3487
Query!
Fax
37916
0
Query!
Email
37916
0
christopher.levi@hnehealth.nsw.gov.au
Query!
No information has been provided regarding IPD availability
Summary results
No Results
Download to PDF