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Taking peoplePhase 2/3

Tests tenecteplase given into the brain artery after clot removal in stroke

Tests a clot-dissolving drug given into the artery after thrombectomy in adults with stroke.

Plain-language title generated from the registry record
Registry title: Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Key facts

Where
Christchurch, New ZealandSee the site
Phase
Phase 2/3

Where in New Zealand

  • Christchurch HospitalChristchurch, New ZealandNot yet recruiting

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Trial details

Who runs it
University of Melbourne
Trial code
NCT05892510
Record updated
18 May 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Alteplase being infused within 30 minutes (~5x half-life) of anticipated trial drug administration; Intracranial hemorrhage identified by CT or MRI; Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated; Known terminal illness such that the participants would not be expected to survive a year; Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted; 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; Contraindication to imaging with contrast agents; Pregnant women; Current participation in another intervention research study that includes experimental interventions beyond standard-of-care; Other standard contraindications to thrombolysis apart from time window; Planned withdrawal of care or comfort care measures.

ClinicalTrials.gov NCT05892510