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

Last updated: July 21, 2025
Sponsor: University of Melbourne
Overall Status: Active - Recruiting

Phase

2/3

Condition

Blood Clots

Cerebral Ischemia

Mental Disability

Treatment

Intra-arterial tenecteplase injection at the completion of thrombectomy

Placebo

Clinical Study ID

NCT05892510
CT26024
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVOon CT/MR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomyusing standard criteria within 24 hours of onset:

  • For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above andASPECTS≥3 on NCCT

  • For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusionof core volume <100ml.

  • Qualifying CT/MR within 4hrs of randomisation (repeat CT for transferredparticipants required if >4hr)

  • Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disabilitypermitted)

  • Local legal requirements for consent have been satisfied.

Exclusion

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 hoursfrom symptoms onset

  • Anticipated endovascular stenting required for intracranial or extracranialatherosclerotic stenosis/occlusion.

  • More than six retrieval attempts in the same vessel

  • Alteplase being infused within 30 minutes (~5x half-life) of anticipated trial drugadministration

  • Contraindication to imaging with contrast agents

  • Any condition (eg.mid-arterial phase early venous filling) that in the judgment ofinvestigators could impose hazards if study therapy is initiated

  • Pregnant women.

  • Current participation in another intervention research study that includesexperimental interventions beyond standard-of-care.

  • Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumabare permitted.

  • Other standard contraindications to thrombolysis apart from time window.

  • Known terminal illness such that the participants would not be expected to survive ayear.

  • Planned withdrawal of care or comfort care measures.

Study Design

Total Participants: 462
Treatment Group(s): 2
Primary Treatment: Intra-arterial tenecteplase injection at the completion of thrombectomy
Phase: 2/3
Study Start date:
June 01, 2024
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Gold Coast Univeristy Hospital

    Gold Coast, Queensland
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane,
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Brisbane,
    Australia

    Site Not Available

  • Canberra Hospital

    Canberra,
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne,
    Australia

    Active - Recruiting

  • Austin Hospital

    Melbourne,
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Melbourne,
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Melbourne,
    Australia

    Active - Recruiting

  • John Hunter Hospital

    Newcastle,
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Perth,
    Australia

    Site Not Available

  • Liverpool Hospital

    Sydney,
    Australia

    Site Not Available

  • Royal North Shore Hospital

    Sydney,
    Australia

    Site Not Available

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