Menu
Recruiting NCT05892510

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

Phase II / Phase III Interventional Ischemic Stroke, Acute Cerebrovascular Disorders Brain Disorder Central Nervous System Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intra-arterial tenecteplase injection at the completion of thrombectomy, Placebo.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder, Central Nervous System Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Intra-arterial tenecteplase injection at the completion of thrombectomy
    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
  • Drug Placebo
    intra-arterial bolus of 0.9% Sodium Chloride solution

Primary outcome measures

  • Early Neurological Improvement (Phase 2b) [Time frame: 24-36 hours from time of randomisation]
  • Functional independence (Phase 3) [Time frame: 3 months]
Secondary outcome measures (6)
  • Functional improvement [Time frame: 3 months]
  • Infarct growth [Time frame: 24 hours]
  • No-reflow [Time frame: 24 hours]
  • Symptomatic Intracerebral Hemorrhage [Time frame: 36 hours]
  • All cause mortality [Time frame: 3 months]
  • Quality of life assessment on EQ-5D [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 11 centers
  • Gold Coast Univeristy Hospital — Gold Coast
  • Royal Adelaide Hospital — Adelaide
  • Alfred Hospital — Melbourne
  • Austin Hospital — Melbourne
  • Monash Medical Centre — Melbourne
  • Royal Melbourne Hospital — Melbourne
  • Fiona Stanley Hospital — Perth
  • Sir Charles Gairdner Hospital — Perth
  • … and 3 more centers
New Zealand · 1 center
  • Christchurch Hospital — Christchurch

Identifiers

NCT: NCT05892510 · CT26024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗