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| Abstract |
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Background
and hypothesis Intravenous thrombolysis with alteplase remains standard care
prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke
onset. However, alteplase only succeeds in reperfusing large vessel arterial
occlusion prior to thrombectomy in a minority of patients. We hypothesized that
tenecteplase is non-inferior to alteplase in achieving reperfusion at initial
angiogram, when administered within 4.5 h of ischemic stroke onset, in patients
planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an
investigator-initiated, phase II, multicenter, prospective, randomized,
open-label, blinded-endpoint non-inferiority study. Eligibility requires a
diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified
Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid,
basilar, or middle cerebral artery) on multimodal computed tomography and
absence of contraindications to intravenous thrombolysis. Patients are
randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase
(0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary
outcome measure is reperfusion on the initial catheter angiogram, assessed as
modified treatment in cerebral infarction 2 b/3 or the absence of retrievable
thrombus. Secondary outcomes include modified Rankin Scale at day 90 and
favorable clinical response (reduction in National Institutes of Health Stroke
Scale by ≥8 points or reaching 0-1) at day 3. Safety outcomes are death and
symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov
NCT02388061. |
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