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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/NCT02388061




Registration number
NCT02388061
Ethics application status
Date submitted
9/03/2015
Date registered
13/03/2015
Date last updated
30/03/2018

Titles & IDs
Public title
Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke
Scientific title
Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase
Secondary ID [1] 0 0
NTA1401
Universal Trial Number (UTN)
Trial acronym
EXTEND-IA TNK
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
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
Treatment: Drugs - Tissue Plasminogen Activator

Experimental: 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


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

Outcomes
Primary outcome [1] 0 0
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
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 [1] 0 0
Initial angiogram (day 0)
Secondary outcome [2] 0 0
Modified Rankin Scale (mRS) at 3 months
Timepoint [2] 0 0
3 months post stroke
Secondary outcome [3] 0 0
mRS 0-1 or no change from baseline at 3 months
Timepoint [3] 0 0
3 months post stroke
Secondary outcome [4] 0 0
mRS 0-2 or no change from baseline at 3 months
Timepoint [4] 0 0
3 months post stroke
Secondary outcome [5] 0 0
Symptomatic intracranial hemorrhage (SICH)
Timepoint [5] 0 0
within 36 hours post treatment
Secondary outcome [6] 0 0
Death due to any cause
Timepoint [6] 0 0
Up to 3 months post stroke
Secondary outcome [7] 0 0
Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram
Timepoint [7] 0 0
Up to 24 hours post treatment

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

2. Patient's age is =18 years

3. Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6
hours of stroke onset.

4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery.
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) identified by CT or MRI

2. Rapidly improving symptoms at the discretion of the investigator

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

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

5. Contra indication to imaging with contrast agents

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

7. 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.

8. 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
Open (masking not used)
Who is / are masked / blinded?



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
23/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2018
Sample size
Target
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [11] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [12] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [13] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [14] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [15] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [16] 0 0
Western Heath - St Albans
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Gold Coast
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
- Heidelberg
Recruitment postcode(s) [14] 0 0
3004 - Melbourne
Recruitment postcode(s) [15] 0 0
3050 - Melbourne
Recruitment postcode(s) [16] 0 0
3021 - St Albans
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 are
eligible for standard intravenous tPA therapy 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 intravenous alteplase or tenecteplase before all participants
undergo intra-arterial clot retrieval. The trial is prospective, randomised, open-label,
blinded endpoint (PROBE) design.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02388061
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/NCT02388061