Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
NCT ID: NCT05892510
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
462 participants
INTERVENTIONAL
2024-06-01
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Intra-arterial bolus of placebo (0.9% Sodium Chloride solution) representing standard of care (no intra-arterial thrombolytic treatment).
Placebo
intra-arterial bolus of 0.9% Sodium Chloride solution
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
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
Interventions
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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
Placebo
intra-arterial bolus of 0.9% Sodium Chloride solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Melbourne
OTHER
Responsible Party
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Locations
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Gold Coast Univeristy Hospital
Gold Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Princess Alexandra Hospital
Brisbane, , Australia
Royal Brisbane and Women's Hospital
Brisbane, , Australia
Canberra Hospital
Canberra, , Australia
Alfred Hospital
Melbourne, , Australia
Austin Hospital
Melbourne, , Australia
Monash Medical Centre
Melbourne, , Australia
Royal Melbourne Hospital
Melbourne, , Australia
John Hunter Hospital
Newcastle, , Australia
Fiona Stanley Hospital
Perth, , Australia
Liverpool Hospital
Sydney, , Australia
Royal North Shore Hospital
Sydney, , Australia
Countries
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Central Contacts
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Facility Contacts
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Peter Bailey
Role: primary
Roy Drew
Role: primary
Michael Devlin
Role: primary
Andrew Wong
Role: primary
Peter Mews
Role: primary
Pamela Galindo
Role: primary
Vincent Thijs
Role: primary
Henry Ma
Role: primary
David Jackson
Role: primary
Linda Belevski
Role: primary
Darshan Ghia
Role: primary
Dennis Cordato
Role: primary
Alice Ma
Role: primary
Other Identifiers
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CT26024
Identifier Type: -
Identifier Source: org_study_id
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