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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllUniversity of Melbourne
NCT05892510 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Intra-arterial tenecteplase injection at the completion of thrombectomy
  • Placebo
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Where

12 sites
Gold Coast Univeristy Hospital
Gold Coast, Australia
Royal Adelaide Hospital
Adelaide, Australia
Alfred Hospital
Melbourne, Australia
Austin Hospital
Melbourne, Australia
Monash Medical Centre
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
Fiona Stanley Hospital
Perth, Australia
Sir Charles Gairdner Hospital
Perth, Australia

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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