Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke
Ischemic Stroke, Acute, Cerebrovascular Disorders, Brain Disorder
About this trial
This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Tenecteplase, Fibrinolytic agents, Thrombectomy, No-reflow
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.
Sites / Locations
- Royal Adelaide Hospital
- Princess Alexandra Hospital
- Royal Brisbane and Women's Hospital
- Canberra Hospital
- Alfred Hospital
- Austin Hospital
- Monash Medical Centre
- Royal Melbourne Hospital
- John Hunter Hospital
- Fiona Stanley Hospital
- Liverpool Hospital
- Royal North Shore Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Intra-arterial tenecteplase injection at the completion of thrombectomy
Intra-arterial bolus of placebo (0.9% Sodium Chloride solution) representing standard of care (no intra-arterial thrombolytic treatment).
intra-arterial tenecteplase (0.062mg/kg, maximum 6.25mg) administered as a bolus at the completion of thrombectomy through a microcatheter at the site of the initial-but-now-retrieved intracranial occlusion or in direct contact with the residual thrombus