Trial from ANZCTR


Trial ID ACTRN12608000466347
Trial Status: Registered
Date Submitted: 2/09/2008
Date Registered: 17/09/2008
Prospectively registered

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Public title Low-dose tenecteplase versus standard-dose alteplase for acute ischaemic stroke: an Imaging-Based Efficacy Trial.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Low-dose tenecteplase versus standard-dose alteplase for acute ischaemic stroke: an Imaging-Based Efficacy Trial.
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Secondary ID [1] 273177 0
Tenecteplase versus Alteplase for Acute Ischaemic Stroke (TAAIS) Trial
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Ischaemic stroke 3635 0
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Condition category: Condition code:
Neurological Other neurological disorders
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3800 3800 0 0
Stroke Ischaemic
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3844 3844 0 0

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Descriptions of intervention(s) / exposure Tenecteplase: given as a single intravenous bolus (over one minute), in one of two doses (0.1mg/kg or 0.25 mg/kg)
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Treatment: drugs 3348 0
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Comparator / control treatment Alteplase: given intravenously 0.9mg/kg, 10% as a bolus (over one minute) and the remaining 90% as a one hour infusion immediately following the bolus
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Control group Active
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Primary Outcome: Reperfusion: This will be measured by the proportional reduction in the size of the pre-treatment perfusion lesion (mean transit time) on perfusion computed tomography (CTP) or magnetic resonance imaging (MRI), and the 24 hour post-treatment MRI perfusion lesion. 4696 0
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Timepoint: Baseline and 24 hours 4696 0
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Primary Outcome: Early Clinical Improvement: This will be determined by change in the NIHSS (National Institutes of Health Stroke Scale) score from pre-treatment to 24 hours. 4697 0
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Timepoint: Baseline and 24 hours 4697 0
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Secondary Outcome: Intra-cranial haemorrhage (ICH): Proportion with parenchymal haematoma (PH type 1 or PH type 2) on 24 hour MRI 7916 0
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Timepoint: 24 hours 7916 0
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Secondary Outcome: Proportion with parenchymal haematoma type 2 (PH2) on 24 hour MRI 7917 0
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Timepoint: Baseline and 24 hour perfusion CT and MRI 7917 0
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Secondary Outcome: Proportion with complete vessel recanalisation on 24 hour MRA 7918 0
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Timepoint: 24 hours 7918 0
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Secondary Outcome: Infarct growth between acute CTP and 24 hour MRI - measured in absolute volume change (mL) 7919 0
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Timepoint: baseline and 24 hours 7919 0
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Secondary Outcome: Infarct growth between acute CTP and day 90 MRI - measured in absolute volume change (mL) 7920 0
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Timepoint: Baseline and day 90 7920 0
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Secondary Outcome: Proportion with early major neurologic improvement at 24 hours (NIHSS reduction of 8 or more) 7921 0
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Timepoint: Baseline and 24 hours 7921 0
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Secondary Outcome: Proportion with good functional outcome: defined as a modified Rankin Scale (mRS) of 0-2 7922 0
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Timepoint: day 90 7922 0
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Secondary Outcome: Proportion of patients with symptomatic ICH (PH2 + decline of 4 or more points on NIHSS) at 24 hours 294368 0
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Timepoint: 24 hours 294368 0
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Secondary Outcome: Proportion of patients with excellent functional outcome: defined as a modified Rankin Scale (mRS) of 0-1 at 90 days 294369 0
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Timepoint: 90 days 294369 0
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Secondary Outcome: Proportion of patients with poor functional outcome: defined as a modified Rankin Scale (mRS) of 5-6 at 90 days 294370 0
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Timepoint: 90 days 294370 0
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Secondary Outcome: Proportional reperfusion at 24 hours (non-parametric measured) 294371 0
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Timepoint: 24 hours 294371 0
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Secondary Outcome: Proportion of patients with complete or partial recanalisation on MRA (MR angiogram) at 24 hours. 294372 0
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Timepoint: 24 hours 294372 0
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Secondary Outcome: Change in acute to 24 hour NIHSS (non-parametric measured) 294373 0
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Timepoint: 24 hours 294373 0
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Secondary Outcome: Proportion of patients dying before 90 days 294374 0
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Timepoint: 90 days 294374 0
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Secondary Outcome: The above analyses will be performed on pooled TNK vs tPA group. Should there be significant differences in the primary outcomes the above analyses will be repeated between the individual treatment groups 294375 0
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Timepoint: 24 hours and 90 days 294375 0
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Key inclusion criteria Patients presenting with acute ischaemic stroke, onset within previous 6 hours. Fulfilling usual clinical criteria for thrombolytic treatment. Specific additional advanced imaging criteria:

Imaging inclusion criteria:
CT or MR scanning has excluded intracranial haemorrhage
CT angiography (CTA) shows a visible vessel occlusion (complete or partial) – this may be in middle, anterior or posterior cerebral artery, and should be anatomically correlated with the perfusion CT (CTP) lesion
CTP or MRI shows >20% ‘mismatch’ between mean transit time (MTT) lesion and cerebral blood volume (CBV) or DWI lesion (i.e. significant penumbral tissue) – this is visually assessed.
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Minimum age 18 Years
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Maximum age 85 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Standard clinical exclusion criteria for stroke thrombolysis apply.
Specific imaging exclusion criteria:
Severe renal impairment - Glomerular filtration rate (GFR) <15 mls/min
Contraindication to MRI (pacemaker, aneurysm clips)
No perfusion lesion visible and/or no visible vessel occlusion (in middle, anterior, or posterior cerebral arteries)
‘Match’ between cerebral blood volume (CBV) or diffusion-weighted MRI (DWI) lesion and MTT lesion (i.e. no penumbra).
Large area of irreversible ischaemia (>1/3 middle cerebral artery territory on CBV, or DWI)
Internal carotid occlusion on side of acutely affected hemisphere or carotid ‘T’ thrombus (as this may be more effectively treated with intra-arterial therapy)
Evidence of acute brainstem ischaemia
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Treatment allocation is via a centralised telephone service, manned by the central study coordinator. Treatment allocation occurs via phone call to the central study coordinator who opens a sealed opaque envelope envelope (next in sequence) and informs the investigator of the allocation. The only person who has access to the sealed opaque envelopes (locked in a filing cabinet) is the central study coordinator.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Permuted block randomisation
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 1/11/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 75
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2305 1127 0
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Postcode: 3128 1128 0
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Postcode: 3084 1129 0
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Postcode: 3052 1130 0
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Recruitment outside Australia

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Funding Source: Government body 3813 0
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Name: National Health and Medical Research Council (NHMRC) Project Grant: ID 510722 3813 0
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Address: Level 5, 20 Allara Street
Canberra ACT 2601
3813 0
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Country: Australia 3813 0
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Primary Sponsor Hospital
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Name: John Hunter Hospital, University of Newcastle
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Address: 1 Lookout Road
New Lambton Heights, Newcastle, NSW 2305
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Country: Australia
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Secondary Sponsor: None 3422 0
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Name: 3422 0
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Address: 3422 0
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Country: 3422 0
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Other Collaborator: Hospital 395 0
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Name: Box Hill Hospital 395 0
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Address: 1 Nelson Road
Box Hill Melbourne, VIC 3128
395 0
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Country: Australia 395 0
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Other Collaborator: Hospital 396 0
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Name: Austin Hospital 396 0
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Address: 145 Studley Road
Heidelberg Melbourne VIC 3084
396 0
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Country: Australia 396 0
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Other Collaborator: Hospital 397 0
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Name: Royal Melbourne Hospital 397 0
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Address: Corner Grattan Street and Sydney Road
Parkville, Melbourne, VIC 3050
397 0
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Country: Australia 397 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Eastern Health Research and Ethics Committee 5939 0
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Address: 16 Arnold Street
Box Hill
VIC 3128
5939 0
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Country: Australia 5939 0
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Approval Date: 12/09/2008 5939 0
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Submitted Date: 5939 0
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HREC: E07/0809 5939 0
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Brief summary This is a trial of thrombolytic (clot-dissolving) treatment for acute stroke comparing the standard medication alteplase to a newer agent, tenecteplase
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Mark Parsons
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Address: Department of Neurology John Hunter Hospital 1 Lookout Road New Lambton Heights NSW 2305
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Tel: +61249213490
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Email: mark.parsons@hnehealth.nsw.gov.au
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Contact person for scientific queries
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Name: Dr Mark Parsons
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Address: Department of Neurology John Hunter Hospital 1 Lookout Road New Lambton Heights NSW 2305
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Email: mark.parsons@hnehealth.nsw.gov.au
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Contact person responsible for updating information
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Name: Dr Mark Parsons
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Address: Department of Neurology John Hunter Hospital 1 Lookout Road New Lambton Heights NSW 2305
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Country: Australia
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Email: mark.parsons@hnehealth.nsw.gov.au
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Addition Cancer fields
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