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Int J Stroke. 2018 Apr;13(3):328-334. doi: 10.1177/1747493017733935. Epub 2017 Sep 27.

Tenecteplase versus alteplase before endovascular thrombectomy (EXTEND-IA TNK): A multicenter, randomized, controlled study.

Author information

1
1 Department of Medicine and Neurology, Melbourne Brain Centre at the 90134 Royal Melbourne Hospital , 37024 University of Melbourne , Parkville, Victoria, Australia.
2
2 Department of Radiology, the 90134 Royal Melbourne Hospital , 37024 University of Melbourne , Parkville, Victoria, Australia.
3
3 56369 Florey Institute of Neuroscience and Mental Health , 37024 University of Melbourne , Parkville, Australia.
4
4 1062 Royal Adelaide Hospital , Adelaide, South Australia, Australia.
5
5 Department of Neurosciences, Eastern Health and Eastern Health Clinical School, Monash University, Clayton, Victoria, Australia.
6
6 96043 Austin Hospital , Austin Health, Heidelberg, Victoria, Australia.
7
7 School of Medicine, Faculty of Health, Deakin University, Victoria, Australia.
8
8 Christchurch Hospital, Christchurch, New Zealand.
9
9 1966 Princess Alexandra Hospital , Brisbane, Queensland, Australia.
10
10 Department of Medicine and Neurology, Melbourne Medical School, The 37024 University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.
11
11 Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.
12
12 Royal Prince 5390 Alfred Hospital , Camperdown, New South Wales, Australia.
13
13 Royal North Shore Hospital, St Leonards, New South Wales, Australia.
14
14 Westmead Hospital, Sydney, New South Wales, Australia.
15
15 60093 Gold Coast University Hospital , Southport, Queensland, Australia.
16
16 Royal Brisbane & Women's Hospital, University of Queensland, Brisbane, Queensland, Australia.
17
17 Auckland Hospital, University of Auckland, Auckland, New Zealand.
18
18 3187 Lyell McEwin Hospital , Adelaide, South Australia, Australia.
19
19 Monash Medical Centre, Monash University, Clayton, Victoria, Australia.
20
20 5390 Alfred Hospital , Monash University, Prahran Victoria, Australia.
21
21 90112 Gosford Hospital , Gosford, New South Wales, Australia.

Abstract

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.

KEYWORDS:

CT perfusion; Ischemic stroke; alteplase; endovascular thrombectomy; intra-arterial clot retrieval; randomized trial; tenecteplase; thrombolysis; tissue plasminogen activator

PMID:
28952914
DOI:
10.1177/1747493017733935
[Indexed for MEDLINE]

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