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.
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)
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.
University of Melbourne
Lead sponsor