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Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke (EXTEND-IA TNK)

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ClinicalTrials.gov Identifier: NCT02388061
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Neuroscience Trials Australia

Tracking Information
First Submitted Date  ICMJE March 9, 2015
First Posted Date  ICMJE March 13, 2015
Last Update Posted Date March 30, 2018
Actual Study Start Date  ICMJE March 23, 2015
Actual Primary Completion Date October 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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. [ Time Frame: Initial angiogram (day 0) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Proportion of patients with substantial angiographic reperfusion (assessed as a modified Treatment In Cerebral Ischemia (mTICI) score of 2b/3 (restoration of blood flow to >50% of the affected arterial territory) at initial angiogram. [ Time Frame: Initial angiogram (day 0) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • 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. [ Time Frame: Initial angiogram (day 0) ]
  • Modified Rankin Scale (mRS) at 3 months [ Time Frame: 3 months post stroke ]
    ordinal analysis
  • mRS 0-1 or no change from baseline at 3 months [ Time Frame: 3 months post stroke ]
  • mRS 0-2 or no change from baseline at 3 months [ Time Frame: 3 months post stroke ]
  • Symptomatic intracranial hemorrhage (SICH) [ Time Frame: within 36 hours post treatment ]
  • Death due to any cause [ Time Frame: Up to 3 months post stroke ]
  • Proportion of patients with angiographic reperfusion adjusted for hyperdense clot length on non-contrast CT and time from thrombolysis to initial angiogram [ Time Frame: Up to 24 hours post treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • Proportion of patients with complete angiographic reperfusion (mTICI 3) at initial angiogram. [ Time Frame: Initial angiogram (day 0) ]
  • Median percentage reperfusion at 24 hrs post stroke, adjusted for site of occlusion (CT or MR perfusion imaging). [ Time Frame: 24 hours post stroke onset ]
  • Favourable clinical response at 3 days [ Time Frame: 3 days post stroke ]
    National Institutes of Health Stroke Score (NIHSS) reduction >/= 8 points or reaching 0-1 at 3 days adjusted for baseline NIHSS and age
  • Modified Rankin Scale (mRS) at 3 months [ Time Frame: 3 months post stroke ]
    ordinal analysis
  • mRS 0-1 or no change from baseline at 3 months [ Time Frame: 3 months post stroke ]
  • mRS 0-2 or no change from baseline at 3 months [ Time Frame: 3 months post stroke ]
  • Symptomatic intracranial hemorrhage (SICH) assessed as a large parenchymal hematoma on CT or MR within 36hr of treatment combined with a clinical deterioration of >/= 4 points on the National Institutes of Health Stroke Scale Score (NIHSS) [ Time Frame: within 36 hours post treatment ]
  • Death due to any cause [ Time Frame: 3 months post stroke ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke
Official Title  ICMJE Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Drug: Tenecteplase
    Other Name: TNK
  • Drug: Tissue Plasminogen Activator
    Other Names:
    • Alteplase
    • tPA
Study Arms  ICMJE
  • Experimental: Intravenous tenecteplase (TNK)
    Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).
    Intervention: Drug: Tenecteplase
  • 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.
    Intervention: Drug: Tissue Plasminogen Activator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
202
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2015)
64
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date October 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02388061
Other Study ID Numbers  ICMJE NTA1401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neuroscience Trials Australia
Study Sponsor  ICMJE Neuroscience Trials Australia
Collaborators  ICMJE The Florey Institute of Neuroscience and Mental Health
Investigators  ICMJE Not Provided
PRS Account Neuroscience Trials Australia
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP