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Completed

NCT Number: NCT02388061

Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Intra-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.
  • Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery.

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

Treatment and study plan

Tenecteplase

Drug

Other names: TNK

tissue plasminogen activator

Drug

Other names: Alteplase, tPA

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Modified Rankin Scale (mRS) at 3 months

    Time frame: 3 months post stroke

    ordinal analysis

  3. mRS 0-1 or no change from baseline at 3 months

    Time frame: 3 months post stroke

  4. mRS 0-2 or no change from baseline at 3 months

    Time frame: 3 months post stroke

  5. Symptomatic intracranial hemorrhage (SICH)

    Time frame: within 36 hours post treatment

  6. Death due to any cause

    Time frame: Up to 3 months post stroke

  7. 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

Sponsors and collaborators

Lead sponsor

Neuroscience Trials Australia

Other

Collaborators

  • The Florey Institute of Neuroscience and Mental Health

Registry information

Official study title

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

Acronym: EXTEND-IA TNK

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 13, 2015
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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