European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.
Identifieur interne : 002279 ( PubMed/Curation ); précédent : 002278; suivant : 002280European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.
Auteurs : Hemasse Amiri [Allemagne] ; Erich Bluhmki [Allemagne] ; Martin Bendszus [Allemagne] ; Christoph C. Eschenfelder [Allemagne] ; Geoffrey A. Donnan [Australie] ; Didier Leys [France] ; Carlos Molina [Espagne] ; Peter A. Ringleb [Allemagne] ; Peter D. Schellinger [Allemagne] ; Stefan Schwab [Allemagne] ; Danilo Toni [Italie] ; Nils Wahlgren [Suède] ; Werner Hacke [Allemagne]Source :
- International journal of stroke : official journal of the International Stroke Society [ 1747-4949 ] ; 2016.
Descripteurs français
- KwdFr :
- Accident vasculaire cérébral (traitement médicamenteux), Activateur tissulaire du plasminogène (administration et posologie), Activateur tissulaire du plasminogène (usage thérapeutique), Administration par voie intraveineuse, Facteurs temps, Humains, Imagerie par résonance magnétique, Méthode en double aveugle, Neuroimagerie, Protocoles cliniques (normes), Résultat thérapeutique, Traitement thrombolytique ().
- MESH :
- administration et posologie : Activateur tissulaire du plasminogène.
- normes : Protocoles cliniques.
- traitement médicamenteux : Accident vasculaire cérébral.
- usage thérapeutique : Activateur tissulaire du plasminogène.
- Administration par voie intraveineuse, Facteurs temps, Humains, Imagerie par résonance magnétique, Méthode en double aveugle, Neuroimagerie, Résultat thérapeutique, Traitement thrombolytique.
English descriptors
- KwdEn :
- Administration, Intravenous, Clinical Protocols (standards), Double-Blind Method, Humans, Magnetic Resonance Imaging, Neuroimaging, Stroke (drug therapy), Thrombolytic Therapy (methods), Time Factors, Tissue Plasminogen Activator (administration & dosage), Tissue Plasminogen Activator (therapeutic use), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Tissue Plasminogen Activator.
- drug therapy : Stroke.
- methods : Thrombolytic Therapy.
- standards : Clinical Protocols.
- chemical , therapeutic use : Tissue Plasminogen Activator.
- Administration, Intravenous, Double-Blind Method, Humans, Magnetic Resonance Imaging, Neuroimaging, Time Factors, Treatment Outcome.
Abstract
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.
DOI: 10.1177/1747493015620805
PubMed: 26783318
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pubmed:26783318Le document en format XML
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<term>Méthode en double aveugle</term>
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
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<Title>International journal of stroke : official journal of the International Stroke Society</Title>
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<ArticleTitle>European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.</ArticleTitle>
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<Abstract><AbstractText Label="RATIONALE AND HYPOTHESIS" NlmCategory="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.</AbstractText>
<AbstractText Label="STUDY DESIGN" NlmCategory="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.</AbstractText>
<AbstractText Label="STUDY OUTCOME" NlmCategory="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.</AbstractText>
<CopyrightInformation>© 2016 World Stroke Organization.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Amiri</LastName>
<ForeName>Hemasse</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany Hemasse.Amiri@med.uni-heidelberg.de.</Affiliation>
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<Author ValidYN="Y"><LastName>Bluhmki</LastName>
<ForeName>Erich</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Statistics, Boehringer Ingelheim, Bieberach, Germany.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Bendszus</LastName>
<ForeName>Martin</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Neuroradiology, University Hospital Heidelberg, Heidelberg, Germany.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Eschenfelder</LastName>
<ForeName>Christoph C</ForeName>
<Initials>CC</Initials>
<AffiliationInfo><Affiliation>Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Donnan</LastName>
<ForeName>Geoffrey A</ForeName>
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<AffiliationInfo><Affiliation>Florey Neuroscience Institutes, University of Melbourne, Parkville, Australia.</Affiliation>
</AffiliationInfo>
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<ForeName>Didier</ForeName>
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<ForeName>Carlos</ForeName>
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</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Ringleb</LastName>
<ForeName>Peter A</ForeName>
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<AffiliationInfo><Affiliation>Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Schellinger</LastName>
<ForeName>Peter D</ForeName>
<Initials>PD</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Johannes-Wesling-Medical-Centre Minden, Minden, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schwab</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University of Erlangen-Nuernberg, Erlangen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Toni</LastName>
<ForeName>Danilo</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Emergency Department Stroke Unit, La Sapienza University Hospital, Rome, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wahlgren</LastName>
<ForeName>Nils</ForeName>
<Initials>N</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, Karolinska University Hospital-Solna, Solna, Sweden.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Hacke</LastName>
<ForeName>Werner</ForeName>
<Initials>W</Initials>
<AffiliationInfo><Affiliation>Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
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<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Int J Stroke</MedlineTA>
<NlmUniqueID>101274068</NlmUniqueID>
<ISSNLinking>1747-4930</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>EC 3.4.21.68</RegistryNumber>
<NameOfSubstance UI="D010959">Tissue Plasminogen Activator</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D061605" MajorTopicYN="N">Administration, Intravenous</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002985" MajorTopicYN="N">Clinical Protocols</DescriptorName>
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<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008279" MajorTopicYN="N">Magnetic Resonance Imaging</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D059906" MajorTopicYN="N">Neuroimaging</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D020521" MajorTopicYN="N">Stroke</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015912" MajorTopicYN="N">Thrombolytic Therapy</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010959" MajorTopicYN="N">Tissue Plasminogen Activator</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">acute stroke therapy</Keyword>
<Keyword MajorTopicYN="Y">clinical trial</Keyword>
<Keyword MajorTopicYN="Y">ischemic stroke</Keyword>
<Keyword MajorTopicYN="Y">magnetic resonance imaging</Keyword>
<Keyword MajorTopicYN="Y">recombinant tissue plasminogen activator</Keyword>
<Keyword MajorTopicYN="Y">thrombolytic therapy</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>1</Month>
<Day>20</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>1</Month>
<Day>20</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>5</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">26783318</ArticleId>
<ArticleId IdType="pii">11/2/260</ArticleId>
<ArticleId IdType="doi">10.1177/1747493015620805</ArticleId>
</ArticleIdList>
</PubmedData>
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