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

NCT05892510

RecruitingPhase 2, Phase 3

Sponsor: University of Melbourne

Conditions: Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder, Central Nervous System Diseases

Interventions: Intra-arterial tenecteplase injection at the completion of thrombectomy, Placebo

Countries: Australia, New Zealand

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (12)

Gold Coast, Queensland, Australia
Adelaide, Australia
Melbourne, Australia
Melbourne, Australia
Melbourne, Australia
Melbourne, Australia
Perth, Australia
Perth, Australia
Sydney, Australia
Sydney, Australia
Townsville, Australia
Christchurch, New Zealand