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

March 28, 2018 updated by: Neuroscience Trials Australia

Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Newcastle, New South Wales, Australia
        • John Hunter Hospital
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia
        • Royal Brisbane & Women's Hospital
      • Gold Coast, Queensland, Australia
        • Gold Coast University Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Heidelberg, Victoria, Australia
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • St Albans, Victoria, Australia, 3021
        • Western Heath
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
    • Auckland
      • Grafton, Auckland, New Zealand, 1001
        • Auckland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Tissue Plasminogen Activator
Other Names:
  • Alteplase
  • tPA
Experimental: Intravenous tenecteplase (TNK)
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over ~10 seconds).
Drug: Tenecteplase
Other Names:
  • TNK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Initial angiogram (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Initial angiogram (day 0)
Modified Rankin Scale (mRS) at 3 months
Time Frame: 3 months post stroke
ordinal analysis
3 months post stroke
mRS 0-1 or no change from baseline at 3 months
Time Frame: 3 months post stroke
3 months post stroke
mRS 0-2 or no change from baseline at 3 months
Time Frame: 3 months post stroke
3 months post stroke
Symptomatic intracranial hemorrhage (SICH)
Time Frame: within 36 hours post treatment
within 36 hours post treatment
Death due to any cause
Time Frame: Up to 3 months post stroke
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
Up to 24 hours post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuroscience Trials Australia

Collaborators

The Florey Institute of Neuroscience and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2015

Primary Completion (Actual)

October 16, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTA1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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