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Title: Determining the optimal dose of tenecteplase before endovascular therapy for ischemic stroke (EXTEND-IA TNK Part 2): A multicenter, randomized, controlled study.
Authors: Campbell, Bruce Cv;Mitchell, Peter J;Churilov, Leonid;Yassi, Nawaf;Kleinig, Timothy J;Yan, Bernard;Thijs, Vincent;Desmond, Patricia M;Parsons, Mark W;Donnan, Geoffrey A;Davis, Stephen M
Affiliation: Department of Medicine, Austin Health, University of Melbourne, Heidelberg, Australia
Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia
Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Victoria, Australia
Florey Institute of Neuroscience and Mental Health, University of Melbourne, Victoria, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Issue Date: 30-Sep-2019
EDate: 2019-09-30
Citation: International journal of stroke : official journal of the International Stroke Society 2019; online first: 30 September
Abstract: Intravenous thrombolysis with tenecteplase is more effective than alteplase in achieving substantial reperfusion at initial angiographic assessment and improves functional outcome. However, the optimal dose of tenecteplase remains uncertain. We hypothesized that 0.40 mg/kg tenecteplase is superior to 0.25 mg/kg tenecteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. EXTEND-IA TNK part 2 is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale (mRS)≤3 (no upper age limit), absence of contraindications to intravenous thrombolysis, and large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal CT. Patients are randomized to IV tenecteplase at either 0.40 mg/kg (max 40 mg) or 0.25 mg/kg (max 25 mg) prior to thrombectomy. The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified Treatment In Cerebral Infarction (mTICI) 2b/3, or the absence of retrievable intracranial thrombus. Secondary outcomes include mRS at day 90 and early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) by ≥8 points or reaching 0-1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration: NCT03340493.
DOI: 10.1177/1747493019879652
ORCID: 0000-0003-3632-9433
PubMed URL: 31564231
Type: Journal Article
Subjects: CT perfusion
Ischemic stroke
endovascular thrombectomy
intra-arterial clot retrieval
randomized trial
tissue plasminogen activator
Appears in Collections:Journal articles

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