Intra-arterial tenecteplase given after thrombectomy for anterior large-vessel ischemic stroke with no-reflow or residual clot

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled seamless phase 2b/3 trial using a two-arm (1:1) design to compare intra-arterial tenecteplase versus placebo delivered at the completion of mechanical thrombectomy. Eligible participants are adults with anterior circulation large-vessel occlusion (intracranial ICA, M1, or proximal M2) treated within 24 hours and meeting imaging criteria (ASPECTS ≥3 or core <100 mL for the 6–24 hour window). The intervention is an intra-arterial injection administered after the thrombectomy procedure to target residual non-retrievable thrombus or no-reflow. The trial will measure safety and efficacy outcomes including reperfusion measures and clinical functional recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gold Coast Univeristy Hospital
  Gold Coast, Queensland, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, Australia Recruiting
• Alfred Hospital
  Melbourne, Australia Recruiting
• Austin Hospital
  Melbourne, Australia Recruiting
• Monash Medical Centre
  Melbourne, Australia Recruiting
• Royal Melbourne Hospital
  Melbourne, Australia Recruiting

Study contacts

• Study coordinator: Felix Ng
• Email: ng.f@unimelb.edu.au
• Phone: +03 9342 7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.