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

Launched by UNIVERSITY OF MELBOURNE · May 26, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a medication called tenecteplase to treat patients who have experienced an ischemic stroke, which occurs when a blood clot blocks blood flow to the brain. The study is specifically looking at patients who have undergone a procedure called thrombectomy to remove the clot but still have issues with blood flow afterward. Researchers want to see if giving tenecteplase right after thrombectomy can improve outcomes compared to the best standard care available.

To participate in this trial, individuals need to be at least 18 years old and have a specific type of stroke caused by a blockage in certain brain arteries. They should be treated with thrombectomy within 24 hours of their symptoms starting, and they must meet certain imaging and health criteria. Participants will be randomly assigned to receive either tenecteplase or a placebo (a treatment that looks the same but has no active medication) to compare the effects. It’s important to know that this trial is not yet recruiting participants, so no one can sign up at this time.

Gender

ALL

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.