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NCT Number: NCT05892510

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

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Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Brain Disorder Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Gold Coast Univeristy Hospital, Gold Coast, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVO on CT/MR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomy using standard criteria within 24 hours of onset:
  • For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above and ASPECTS≥3 on NCCT
  • For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusion of core volume <100ml.
  • Qualifying CT/MR within 4hrs of randomisation (repeat CT for transferred participants required if >4hr)
  • Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disability permitted)
  • Local legal requirements for consent have been satisfied.

Exclusion criteria

  • Intracranial hemorrhage identified by CT or MRI
  • ASPECTS 0-2 on NCCT
  • CTP or MRI perfusion ischemic core volume >100ml if presenting within 6-24 hours from symptoms onset
  • Anticipated endovascular stenting required for intracranial or extracranial atherosclerotic stenosis/occlusion.
  • More than six retrieval attempts in the same vessel
  • Alteplase being infused within 30 minutes (~5x half-life) of anticipated trial drug administration
  • Contraindication to imaging with contrast agents
  • Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated
  • Pregnant women.
  • Current participation in another intervention research study that includes experimental interventions beyond standard-of-care.
  • Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted.
  • Other standard contraindications to thrombolysis apart from time window.
  • Known terminal illness such that the participants would not be expected to survive a year.
  • Planned withdrawal of care or comfort care measures.

Treatment and study plan

Intra-arterial tenecteplase injection at the completion of thrombectomy

Drug

Intra-arterial tenecteplase (0.062mg/kg, maximum 6.25mg) administered as a bolus at the completion of thrombectomy through a microcatheter at the site of the initial-but-now-retrieved intracranial occlusion, or in direct contact with the residual thrombus

Placebo

Drug

intra-arterial bolus of 0.9% Sodium Chloride solution

Primary outcomes

  1. Early Neurological Improvement (Phase 2b)

    Time frame: 24-36 hours from time of randomisation

    Proportion of participants with Early Neurological Improvement (ENI) defined as NIHSS reduction>4

  2. Functional independence (Phase 3)

    Time frame: 3 months

    Proportion of participants with Modified Rankin Scale (mRS) 0-2 (functional independence)

Secondary outcomes

  1. Functional improvement

    Time frame: 3 months

    Reduction of ≥ 1 mRS category (ordinal analysis merging mRS categories 5-6)

  2. Infarct growth

    Time frame: 24 hours

    Infarct growth volume on follow-up MRI or CT

  3. No-reflow

    Time frame: 24 hours

    Proportion of participants with radiological no-reflow on MR perfusion or CTP

  4. Symptomatic Intracerebral Hemorrhage

    Time frame: 36 hours

    Proportion of participants with sICH defined as parenchymal haematoma type 2 (PH2) or SAH/IVH within 36 hours combined with neurological deterioration leading to an increase of NIHSS ≥4 from baseline or leading to death

  5. All cause mortality

    Time frame: 3 months

    Proportion of participants with death due to any cause

  6. Quality of life assessment on EQ-5D

    Time frame: 3 months

    EQ-5D score

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Ng

CONTACT

[email protected]

+03 9342 7000

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Registry information

Official study title

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2023
Registry last updated
May 18, 2026

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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