European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.
Identifieur interne : 002305 ( PubMed/Corpus ); précédent : 002304; suivant : 002306European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.
Auteurs : Hemasse Amiri ; Erich Bluhmki ; Martin Bendszus ; Christoph C. Eschenfelder ; Geoffrey A. Donnan ; Didier Leys ; Carlos Molina ; Peter A. Ringleb ; Peter D. Schellinger ; Stefan Schwab ; Danilo Toni ; Nils Wahlgren ; Werner HackeSource :
- International journal of stroke : official journal of the International Stroke Society [ 1747-4949 ] ; 2016.
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
Links to Exploration step
pubmed:26783318Le document en format XML
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Eschenfelder</name><affiliation><nlm:affiliation>Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Donnan, Geoffrey A" sort="Donnan, Geoffrey A" uniqKey="Donnan G" first="Geoffrey A" last="Donnan">Geoffrey A. Donnan</name><affiliation><nlm:affiliation>Florey Neuroscience Institutes, University of Melbourne, Parkville, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Leys, Didier" sort="Leys, Didier" uniqKey="Leys D" first="Didier" last="Leys">Didier Leys</name><affiliation><nlm:affiliation>Department of Neurology, Roger Salengro Hospital, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Molina, Carlos" sort="Molina, Carlos" uniqKey="Molina C" first="Carlos" last="Molina">Carlos Molina</name><affiliation><nlm:affiliation>Department of Neurology, Hospital Vall d'Hebron-Barcelona, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Ringleb, Peter A" sort="Ringleb, Peter A" uniqKey="Ringleb P" first="Peter A" last="Ringleb">Peter A. 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Eschenfelder</name><affiliation><nlm:affiliation>Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Donnan, Geoffrey A" sort="Donnan, Geoffrey A" uniqKey="Donnan G" first="Geoffrey A" last="Donnan">Geoffrey A. Donnan</name><affiliation><nlm:affiliation>Florey Neuroscience Institutes, University of Melbourne, Parkville, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Leys, Didier" sort="Leys, Didier" uniqKey="Leys D" first="Didier" last="Leys">Didier Leys</name><affiliation><nlm:affiliation>Department of Neurology, Roger Salengro Hospital, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Molina, Carlos" sort="Molina, Carlos" uniqKey="Molina C" first="Carlos" last="Molina">Carlos Molina</name><affiliation><nlm:affiliation>Department of Neurology, Hospital Vall d'Hebron-Barcelona, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Ringleb, Peter A" sort="Ringleb, Peter A" uniqKey="Ringleb P" first="Peter A" last="Ringleb">Peter A. Ringleb</name><affiliation><nlm:affiliation>Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Schellinger, Peter D" sort="Schellinger, Peter D" uniqKey="Schellinger P" first="Peter D" last="Schellinger">Peter D. Schellinger</name><affiliation><nlm:affiliation>Department of Neurology, Johannes-Wesling-Medical-Centre Minden, Minden, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Schwab, Stefan" sort="Schwab, Stefan" uniqKey="Schwab S" first="Stefan" last="Schwab">Stefan Schwab</name><affiliation><nlm:affiliation>Department of Neurology, University of Erlangen-Nuernberg, Erlangen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Toni, Danilo" sort="Toni, Danilo" uniqKey="Toni D" first="Danilo" last="Toni">Danilo Toni</name><affiliation><nlm:affiliation>Emergency Department Stroke Unit, La Sapienza University Hospital, Rome, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Wahlgren, Nils" sort="Wahlgren, Nils" uniqKey="Wahlgren N" first="Nils" last="Wahlgren">Nils Wahlgren</name><affiliation><nlm:affiliation>Department of Neurology, Karolinska University Hospital-Solna, Solna, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name><affiliation><nlm:affiliation>Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.</nlm:affiliation></affiliation></author></analytic><series><title level="j">International journal of stroke : official journal of the International Stroke Society</title><idno type="eISSN">1747-4949</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Intravenous</term><term>Clinical Protocols (standards)</term><term>Double-Blind Method</term><term>Humans</term><term>Magnetic Resonance Imaging</term><term>Neuroimaging</term><term>Stroke (drug therapy)</term><term>Thrombolytic Therapy (methods)</term><term>Time Factors</term><term>Tissue Plasminogen Activator (administration & dosage)</term><term>Tissue Plasminogen Activator (therapeutic use)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Tissue Plasminogen Activator</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Stroke</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Thrombolytic Therapy</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Clinical Protocols</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Tissue Plasminogen Activator</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Intravenous</term><term>Double-Blind Method</term><term>Humans</term><term>Magnetic Resonance Imaging</term><term>Neuroimaging</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26783318</PMID><DateCreated><Year>2016</Year><Month>01</Month><Day>19</Day></DateCreated><DateCompleted><Year>2017</Year><Month>05</Month><Day>03</Day></DateCompleted><DateRevised><Year>2017</Year><Month>05</Month><Day>03</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1747-4949</ISSN><JournalIssue CitedMedium="Internet"><Volume>11</Volume><Issue>2</Issue><PubDate><Year>2016</Year><Month>Feb</Month></PubDate></JournalIssue><Title>International journal of stroke : official journal of the International Stroke Society</Title><ISOAbbreviation>Int J Stroke</ISOAbbreviation></Journal><ArticleTitle>European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND.</ArticleTitle><Pagination><MedlinePgn>260-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1177/1747493015620805</ELocationID><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></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bluhmki</LastName><ForeName>Erich</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Statistics, Boehringer Ingelheim, Bieberach, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bendszus</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Neuroradiology, University Hospital Heidelberg, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><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></Author><Author ValidYN="Y"><LastName>Donnan</LastName><ForeName>Geoffrey A</ForeName><Initials>GA</Initials><AffiliationInfo><Affiliation>Florey Neuroscience Institutes, University of Melbourne, Parkville, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leys</LastName><ForeName>Didier</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Neurology, Roger Salengro Hospital, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Molina</LastName><ForeName>Carlos</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Neurology, Hospital Vall d'Hebron-Barcelona, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ringleb</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Department of Neurology, University Hospital Heidelberg, Heidelberg, Germany.</Affiliation></AffiliationInfo></Author><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></Author><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><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><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><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><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 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