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https://hdl.handle.net/1/2696
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DC Field | Value | Language |
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dc.contributor.author | Parsons, Mark W | - |
dc.contributor.author | Yogendrakumar, Vignan | - |
dc.contributor.author | Churilov, Leonid | - |
dc.contributor.author | Garcia-Esperon, Carlos | - |
dc.contributor.author | Campbell, Bruce C V | - |
dc.contributor.author | Russell, Michelle L | - |
dc.contributor.author | Sharma, Gagan | - |
dc.contributor.author | Chen, Chushuang | - |
dc.contributor.author | Lin, Longting | - |
dc.contributor.author | Chew, Beng Lim | - |
dc.contributor.author | Ng, Felix C | - |
dc.contributor.author | Deepak, Akshay | - |
dc.contributor.author | Choi, Philip M C | - |
dc.contributor.author | Kleinig, Timothy J | - |
dc.contributor.author | Cordato, Dennis J | - |
dc.contributor.author | Wu, Teddy Y | - |
dc.contributor.author | Fink, John N | - |
dc.contributor.author | Ma, Henry | - |
dc.contributor.author | Phan, Thanh G | - |
dc.contributor.author | Markus, Hugh S | - |
dc.contributor.author | Molina, Carlos A | - |
dc.contributor.author | Tsai, Chon-Haw | - |
dc.contributor.author | Lee, Jiunn-Tay | - |
dc.contributor.author | Jeng, Jiann-Shing | - |
dc.contributor.author | Strbian, Daniel | - |
dc.contributor.author | Meretoja, Atte | - |
dc.contributor.author | Arenillas, Juan F | - |
dc.contributor.author | Buck, Brian H | - |
dc.contributor.author | Devlin, Michael J | - |
dc.contributor.author | Brown, Helen | - |
dc.contributor.author | Butcher, Ken S | - |
dc.contributor.author | O'Brien, Billy | - |
dc.contributor.author | Sabet, Arman | - |
dc.contributor.author | Wijeratne, Tissa | - |
dc.contributor.author | Bivard, Andrew | - |
dc.contributor.author | Grimley, Rohan S | - |
dc.contributor.author | Agarwal, Smriti | - |
dc.contributor.author | Munshi, Sunil K | - |
dc.contributor.author | Donnan, Geoffrey A | - |
dc.contributor.author | Davis, Stephen M | - |
dc.contributor.author | Miteff, Ferdinand | - |
dc.contributor.author | Spratt, Neil J | - |
dc.contributor.author | Levi, Christopher R | - |
dc.date.accessioned | 2024-08-16T01:26:53Z | - |
dc.date.available | 2024-08-16T01:26:53Z | - |
dc.date.issued | 2024-08 | - |
dc.identifier.citation | 23(8):775-786 | en |
dc.identifier.uri | https://hdl.handle.net/1/2696 | - |
dc.description.abstract | Intravenous tenecteplase increases reperfusion in patients with salvageable brain tissue on perfusion imaging and might have advantages over alteplase as a thrombolytic for ischaemic stroke. We aimed to assess the non-inferiority of tenecteplase versus alteplase on clinical outcomes in patients selected by use of perfusion imaging. This international, multicentre, open-label, parallel-group, randomised, clinical non-inferiority trial enrolled patients from 35 hospitals in eight countries. Participants were aged 18 years or older, within 4·5 h of ischaemic stroke onset or last known well, were not being considered for endovascular thrombectomy, and met target mismatch criteria on brain perfusion imaging. Patients were randomly assigned (1:1) by use of a centralised web server with randomly permuted blocks to intravenous tenecteplase (0·25 mg/kg) or alteplase (0·90 mg/kg). The primary outcome was the proportion of patients without disability (modified Rankin Scale 0-1) at 3 months, assessed via masked review in both the intention-to-treat and per-protocol populations. We aimed to recruit 832 participants to yield 90% power (one-sided alpha=0·025) to detect a risk difference of 0·08, with an absolute non-inferiority margin of -0·03. The trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000243718, and the European Union Clinical Trials Register, EudraCT Number 2015-002657-36, and it is completed. Recruitment ceased early following the announcement of other trial results showing non-inferiority of tenecteplase versus alteplase. Between March 21, 2014, and Oct 20, 2023, 680 patients were enrolled and randomly assigned to tenecteplase (n=339) and alteplase (n=341), all of whom were included in the intention-to-treat analysis (multiple imputation was used to account for missing primary outcome data for five patients). Protocol violations occurred in 74 participants, thus the per-protocol population comprised 601 people (295 in the tenecteplase group and 306 in the alteplase group). Participants had a median age of 74 years (IQR 63-82), baseline National Institutes of Health Stroke Scale score of 7 (4-11), and 260 (38%) were female. In the intention-to-treat analysis, the primary outcome occurred in 191 (57%) of 335 participants allocated to tenecteplase and 188 (55%) of 340 participants allocated to alteplase (standardised risk difference [SRD]=0·03 [95% CI -0·033 to 0·10], one-tailed pnon-inferiority=0·031). In the per-protocol analysis, the primary outcome occurred in 173 (59%) of 295 participants allocated to tenecteplase and 171 (56%) of 306 participants allocated to alteplase (SRD 0·05 [-0·02 to 0·12], one-tailed pnon-inferiority=0·01). Nine (3%) of 337 patients in the tenecteplase group and six (2%) of 340 in the alteplase group had symptomatic intracranial haemorrhage (unadjusted risk difference=0·01 [95% CI -0·01 to 0·03]) and 23 (7%) of 335 and 15 (4%) of 340 died within 90 days of starting treatment (SRD 0·02 [95% CI -0·02 to 0·05]). The findings in our study provide further evidence to strengthen the assertion of the non-inferiority of tenecteplase to alteplase, specifically when perfusion imaging has been used to identify reperfusion-eligible stroke patients. Although non-inferiority was achieved in the per-protocol population, it was not reached in the intention-to-treat analysis, possibly due to sample size limtations. Nonetheless, large-scale implementation of perfusion CT to assist in patient selection for intravenous thrombolysis in the early time window was shown to be feasible. Australian National Health Medical Research Council; Boehringer Ingelheim. | en |
dc.description.sponsorship | Neurology | en |
dc.subject | Neurology | en |
dc.title | Tenecteplase versus alteplase for thrombolysis in patients selected by use of perfusion imaging within 4·5 h of onset of ischaemic stroke (TASTE): a multicentre, randomised, controlled, phase 3 non-inferiority trial | en |
dc.type | Journal Article | en |
dc.identifier.doi | 10.1016/S1474-4422(24)00206-0 | en |
dc.description.pubmeduri | https://pubmed.ncbi.nlm.nih.gov/38880118 | en |
dc.description.affiliates | Central Coast Local Health District | en |
dc.description.affiliates | Gosford Hospital | en |
dc.identifier.journaltitle | The Lancet Neurology | en |
dc.type.studyortrial | Randomized Controlled Clinical Trial/Controlled Clinical Trial | en |
dc.type.content | Text | en |
item.fulltext | No Fulltext | - |
item.grantfulltext | none | - |
item.openairetype | Journal Article | - |
item.cerifentitytype | Publications | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
Appears in Collections: | Neurology |
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