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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03340493




Registration number
NCT03340493
Ethics application status
Date submitted
8/11/2017
Date registered
13/11/2017
Date last updated
4/03/2020

Titles & IDs
Public title
Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2)
Scientific title
EXTEND-IA TNK: Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase Part 2
Secondary ID [1] 0 0
NTA1401a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase

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

Experimental: Tenecteplase - Patients will receive intravenous tenecteplase (0.4mg/kg, maximum 40mg, administered as a bolus over ~10 seconds).


Treatment: Drugs: Tenecteplase
Tenecteplase 0.25mg/kg and 0.4mg/kg are being used

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

Outcomes
Primary outcome [1] 0 0
mTICI - Proportion of patients with substantial angiographic reperfusion (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) or absence of retrievable thrombus at initial angiogram.
Timepoint [1] 0 0
Initial angiogram (day 0)
Secondary outcome [1] 0 0
Modified Rankin Scale (mRS) - mRS ordinal analysis. mRS 0-1 or no change from baseline and mRS 0-2 or no change from baseline.
Timepoint [1] 0 0
at 3 months post stroke
Secondary outcome [2] 0 0
National Institutes of Health Stroke Scale (NIHSS) - Proportion of patients with =8 point reduction in NIHSS or reaching 0-1 at 3 days (favourable clinical response) adjusted for baseline NIHSS and age
Timepoint [2] 0 0
Initial angiogram (day 0)
Secondary outcome [3] 0 0
Symptomatic intracranial haemorrhage (SICH) - SICH is defined as "Intracerebral hemorrhage (parenchymal hematoma type 2 - PH2 within 36 hours of treatment) combined with neurological deterioration leading to an increase of =4 points on the NIHSS"
Timepoint [3] 0 0
Within 36 hours post treatment
Secondary outcome [4] 0 0
Death - Death due to any cause
Timepoint [4] 0 0
Up to 3 months post stroke
Secondary outcome [5] 0 0
Angiographic reperfusion - Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram
Timepoint [5] 0 0
Up to 24 hours post treatment

Eligibility
Key inclusion criteria
- Patients presenting with acute ischemic stroke eligible using standard criteria to
receive IV thrombolysis within 4.5 hours of stroke onset

- Patient's age is =18 years

- Arterial occlusion on CTA (computed tomography angiography) or MRA (Magnetic Resonance
Angiography) of the ICA, M1, M2 or basilar artery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Intracranial hemorrhage (ICH) identified by CT or MRI

- Rapidly improving symptoms at the discretion of the investigator

- Pre-stroke mRS score of = 4 (indicating previous disability)

- Hypodensity in >1/3 MCA territory or equivalent proportion of basilar artery territory
on non-contrast CT

- Contra indication to imaging with contrast agents

- Any terminal illness such that patient would not be expected to survive more than 1
year

- 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.

- Pregnant women

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Albury Hospital - Albury
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 0 0
Gosford Hospital - Gosford
Recruitment hospital [6] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [8] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [11] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [12] 0 0
Sunshine Coast University Hospital - Nambour
Recruitment hospital [13] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [14] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [16] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [17] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [18] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [19] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [20] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [21] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [22] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [23] 0 0
Western Heath - St Albans
Recruitment hospital [24] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [25] 0 0
North East Health Wangaratta - Wangaratta
Recruitment hospital [26] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
2050 - Camperdown
Recruitment postcode(s) [5] 0 0
2250 - Gosford
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
- Newcastle
Recruitment postcode(s) [8] 0 0
2605 - St Leonards
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment postcode(s) [10] 0 0
- Brisbane
Recruitment postcode(s) [11] 0 0
- Gold Coast
Recruitment postcode(s) [12] 0 0
4560 - Nambour
Recruitment postcode(s) [13] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [16] 0 0
3353 - Ballarat
Recruitment postcode(s) [17] 0 0
3128 - Box Hill
Recruitment postcode(s) [18] 0 0
3168 - Clayton
Recruitment postcode(s) [19] 0 0
- Heidelberg
Recruitment postcode(s) [20] 0 0
3004 - Melbourne
Recruitment postcode(s) [21] 0 0
3050 - Melbourne
Recruitment postcode(s) [22] 0 0
3630 - Shepparton
Recruitment postcode(s) [23] 0 0
3021 - St Albans
Recruitment postcode(s) [24] 0 0
3844 - Traralgon
Recruitment postcode(s) [25] 0 0
3677 - Wangaratta
Recruitment postcode(s) [26] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Florey Institute of Neuroscience and Mental Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Patients presenting to the emergency department with acute ischemic stroke, who are eligible
for standard intravenous thrombolysis within 4.5 hours of stroke onset will be assessed for
major vessel occlusion to determine their eligibility for randomization into the trial. If
the patient gives informed consent they will be randomised 50:50 using central computerised
allocation to either 0.4mg/kg or 0.25mg/kg intravenous tenecteplase before all participants
undergo endovascular thrombectomy. The trial is prospective, randomised, open-label, blinded
endpoint (PROBE) design.
Trial website
https://clinicaltrials.gov/show/NCT03340493
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
Other publications