Title :

European cooperative acute stroke study-4: extending the time for thrombolysis in emergency neurological deficits ecass-4: extend

Author(s) :

Amiri, Hemasse [Auteur]
Bluhmki, Erich [Auteur]
Bendszus, Martin [Auteur]
Eschenfelder, Christoph C. [Auteur]
Donnan, Geoffrey A. [Auteur]
LEYS, Didier [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 [TCDV]
Molina, Carlos A. [Auteur]
Ringleb, Peter Arthur [Auteur]
Schellinger, Peter D. [Auteur]
Schwab, Stefan [Auteur]
Toni, Danilo [Auteur]
Wahlgren, Nils [Auteur]
Hacke, Werner [Auteur]

Journal title :

International journal of stroke . official journal of the International Stroke Society

Abbreviated title :

Int. J. Stroke

Volume number :

11

Pages :

260-267

Publication date :

2016-02-01

ISSN :

1747-4930

English keyword(s) :

magnetic resonance imaging
recombinant tissue plasminogen activator
thrombolytic therapy
acute stroke therapy
ischemic stroke
clinical trial

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

OBJECTIVE: Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) is an effective and approved therapy for acute ischemic stroke within 4.5 h of onset except for USA, Canada, Croatia, and Moldovia with ...
Show more >OBJECTIVE: Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) is an effective and approved therapy for acute ischemic stroke within 4.5 h of onset except for USA, Canada, Croatia, and Moldovia with a current 3 h label. We hypothesized that ischemic stroke patients selected with significant penumbral mismatch on magnetic resonance imaging (MRI) at 4.5-9 h after onset of stroke will have improved clinical outcomes when given intravenous rt-PA (alteplase) compared to placebo. METHODS: ECASS-4: ExTEND is an investigator driven, phase 3, randomized, multi-center, double-blind, placebo-controlled study. Ischemic stroke patients presenting within 4.5 and 9 h of stroke onset, who fulfil clinical requirements (National Institutes of Health Stroke Score (NIHSS) 4-26 and pre-stroke modified Rankin Scale (mRS) 0-1) will undergo MRI. Patients who meet imaging criteria (infarct core volume <100 ml, perfusion lesion: infarct core mismatch ratio >1.2 and perfusion lesion minimum volume of 20 ml) additionally will be randomized to either rt-PA or placebo. RESULTS: The primary outcome measure will be the categorical shift in the mRS at day 90. Clinical secondary outcomes will be disability at day 90 dichotomized as favorable outcome mRS 0-1 at day 90. Tertiary endpoints include reduction in the NIHSS by 11 or more points or reaching 0-1 at day 90, reperfusion and recanalization at 24 h post stroke as well as depression, life quality, and cognitive impairment at day 90. Safety endpoints will include symptomatic intracranial hemorrhage (ICH) and death.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
CNRS
Inserm
Université de Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172

Research team(s) :

Troubles cognitifs dégénératifs et vasculaires

Submission date :

2019-11-27T13:38:03Z