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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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Scientific title
EXTEND-IA TNK: Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase Part 2
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Secondary ID [1]
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NTA1401a
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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mTICI
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Assessment method [1]
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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.
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Timepoint [1]
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Initial angiogram (day 0)
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Secondary outcome [1]
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Modified Rankin Scale (mRS)
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Assessment method [1]
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mRS ordinal analysis. mRS 0-1 or no change from baseline and mRS 0-2 or no change from baseline.
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Timepoint [1]
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at 3 months post stroke
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Secondary outcome [2]
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National Institutes of Health Stroke Scale (NIHSS)
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Assessment method [2]
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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
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Timepoint [2]
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Initial angiogram (day 0)
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Secondary outcome [3]
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Symptomatic intracranial haemorrhage (SICH)
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Assessment method [3]
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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"
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Timepoint [3]
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Within 36 hours post treatment
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Secondary outcome [4]
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Death
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Assessment method [4]
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Death due to any cause
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Timepoint [4]
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Up to 3 months post stroke
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Secondary outcome [5]
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Angiographic reperfusion
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Assessment method [5]
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Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram
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Timepoint [5]
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Up to 24 hours post treatment
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2020
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Sample size
Target
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Accrual to date
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Final
300
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Albury Hospital - Albury
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Recruitment hospital [2]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [3]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [4]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [5]
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Gosford Hospital - Gosford
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Recruitment hospital [6]
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Liverpool Hospital - Liverpool
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Recruitment hospital [7]
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John Hunter Hospital - Newcastle
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Recruitment hospital [8]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [9]
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Westmead Hospital - Westmead
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Recruitment hospital [10]
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Royal Brisbane & Women's Hospital - Brisbane
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Recruitment hospital [11]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [12]
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Sunshine Coast University Hospital - Nambour
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Recruitment hospital [13]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [14]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [15]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [16]
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Ballarat Health Services - Ballarat
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Recruitment hospital [17]
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Box Hill Hospital - Box Hill
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Recruitment hospital [18]
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Monash Medical Centre - Clayton
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Recruitment hospital [19]
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Austin Hospital - Heidelberg
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Recruitment hospital [20]
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Alfred Hospital - Melbourne
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Recruitment hospital [21]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [22]
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Goulburn Valley Health - Shepparton
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Recruitment hospital [23]
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Western Heath - St Albans
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Recruitment hospital [24]
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Latrobe Regional Hospital - Traralgon
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Recruitment hospital [25]
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North East Health Wangaratta - Wangaratta
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Recruitment hospital [26]
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South West Healthcare - Warrnambool
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2200 - Bankstown
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Recruitment postcode(s) [3]
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2560 - Campbelltown
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Recruitment postcode(s) [4]
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2050 - Camperdown
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Recruitment postcode(s) [5]
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2250 - Gosford
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Recruitment postcode(s) [6]
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2170 - Liverpool
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Recruitment postcode(s) [7]
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- Newcastle
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Recruitment postcode(s) [8]
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2605 - St Leonards
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment postcode(s) [10]
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- Brisbane
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Recruitment postcode(s) [11]
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- Gold Coast
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Recruitment postcode(s) [12]
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4560 - Nambour
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Recruitment postcode(s) [13]
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4102 - Woolloongabba
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Recruitment postcode(s) [14]
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5000 - Adelaide
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Recruitment postcode(s) [15]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [16]
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3353 - Ballarat
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Recruitment postcode(s) [17]
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3128 - Box Hill
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Recruitment postcode(s) [18]
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3168 - Clayton
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Recruitment postcode(s) [19]
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- Heidelberg
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Recruitment postcode(s) [20]
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3004 - Melbourne
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Recruitment postcode(s) [21]
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3050 - Melbourne
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Recruitment postcode(s) [22]
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3630 - Shepparton
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Recruitment postcode(s) [23]
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3021 - St Albans
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Recruitment postcode(s) [24]
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3844 - Traralgon
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Recruitment postcode(s) [25]
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3677 - Wangaratta
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Recruitment postcode(s) [26]
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3280 - Warrnambool
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Recruitment outside Australia
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Neuroscience Trials Australia
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Address
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Other collaborator category [1]
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Other
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Name [1]
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The Florey Institute of Neuroscience and Mental Health
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03340493
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Trial related presentations / publications
Sarraj A, Albers GW, Mitchell PJ, Hassan AE, Abraham MG, Blackburn S, Sharma G, Yassi N, Kleinig TJ, Shah DG, Wu TY, Hussain MS, Tekle WG, Gutierrez SO, Aghaebrahim AN, Haussen DC, Toth G, Pujara D, Budzik RF, Hicks W, Vora N, Edgell RC, Slavin S, Lechtenberg CG, Maali L, Qureshi A, Rosterman L, Abdulrazzak MA, AlMaghrabi T, Shaker F, Mir O, Arora A, Martin-Schild S, Sitton CW, Churilov L, Gupta R, Lansberg MG, Nogueira RG, Grotta JC, Donnan GA, Davis SM, Campbell BCV; SELECT, EXTEND-IA, EXTEND-IA TNK, and EXTEND-IA TNK Part-II Investigators. Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study. Neurology. 2023 Jan 17;100(3):e336-e347. doi: 10.1212/WNL.0000000000201384. Epub 2022 Oct 26. Yogendrakumar V, Churilov L, Mitchell PJ, Kleinig TJ, Yassi N, Thijs V, Wu TY, Shah DG, Ng FC, Dewey HM, Wijeratne T, Yan B, Desmond PM, Parsons MW, Donnan GA, Davis SM, Campbell BCV; EXTEND-IA TNK Investigators. Safety and Efficacy of Tenecteplase in Older Patients With Large Vessel Occlusion: A Pooled Analysis of the EXTEND-IA TNK Trials. Neurology. 2022 Mar 22;98(12):e1292-e1301. doi: 10.1212/WNL.0000000000013302. Epub 2022 Jan 11. Ng FC, Churilov L, Yassi N, Kleinig TJ, Thijs V, Wu T, Shah D, Dewey H, Sharma G, Desmond P, Yan B, Parsons M, Donnan G, Davis S, Mitchell P, Campbell B. Prevalence and Significance of Impaired Microvascular Tissue Reperfusion Despite Macrovascular Angiographic Reperfusion (No-Reflow). Neurology. 2022 Feb 22;98(8):e790-e801. doi: 10.1212/WNL.0000000000013210. Epub 2021 Dec 14. Alemseged F, Ng FC, Williams C, Puetz V, Boulouis G, Kleinig TJ, Rocco A, Wu TY, Shah D, Arba F, Kaiser D, Di Giuliano F, Morotti A, Sallustio F, Dewey HM, Bailey P, O'Brien B, Sharma G, Bush S, Dowling R, Diomedi M, Churilov L, Yan B, Parsons MW, Davis SM, Mitchell PJ, Yassi N, Campbell BCV; BATMAN study group and EXTEND IA TNK study group. Tenecteplase vs Alteplase Before Endovascular Therapy in Basilar Artery Occlusion. Neurology. 2021 Mar 2;96(9):e1272-e1277. doi: 10.1212/WNL.0000000000011520. Epub 2021 Jan 6. Campbell BCV, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Dowling RJ, Yan B, Bush SJ, Thijs V, Scroop R, Simpson M, Brooks M, Asadi H, Wu TY, Shah DG, Wijeratne T, Zhao H, Alemseged F, Ng F, Bailey P, Rice H, de Villiers L, Dewey HM, Choi PMC, Brown H, Redmond K, Leggett D, Fink JN, Collecutt W, Kraemer T, Krause M, Cordato D, Field D, Ma H, O'Brien B, Clissold B, Miteff F, Clissold A, Cloud GC, Bolitho LE, Bonavia L, Bhattacharya A, Wright A, Mamun A, O'Rourke F, Worthington J, Wong AA, Levi CR, Bladin CF, Sharma G, Desmond PM, Parsons MW, Donnan GA, Davis SM; EXTEND-IA TNK Part 2 investigators. Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1257-1265. doi: 10.1001/jama.2020.1511. Erratum In: JAMA. 2022 Mar 8;327(10):985. doi: 10.1001/jama.2022.2486. Campbell BC, Mitchell PJ, Churilov L, Yassi N, Kleinig TJ, Yan B, Thijs V, Desmond PM, Parsons MW, Donnan GA, Davis SM. Determining the optimal dose of tenecteplase before endovascular therapy for ischemic stroke (EXTEND-IA TNK Part 2): A multicenter, randomized, controlled study. Int J Stroke. 2020 Jul;15(5):567-572. doi: 10.1177/1747493019879652. Epub 2019 Sep 30.
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03340493
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