期刊
INTERNATIONAL JOURNAL OF STROKE
卷 13, 期 3, 页码 328-334出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1747493017733935
关键词
Ischemic stroke; thrombolysis; tissue plasminogen activator; tenecteplase; alteplase; endovascular thrombectomy; intra-arterial clot retrieval; CT perfusion; randomized trial
资金
- National Health and Medical Research Council of Australia [GNT1043242, GNT1035688, GNT1113352, GNT1111972]
- Royal Australasian College of Physicians
- Royal Melbourne Hospital Foundation
- National Heart Foundation
- Stroke Foundation of Australia
Background and hypothesis Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5h 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 4.5h 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 4.5h of stroke onset, pre-stroke modified Rankin Scale3 (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 (0.9mg/kg, max 90mg) or tenecteplase (0.25mg/kg, max 25mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2b/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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