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Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2 × 2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment.

Identifieur interne : 002C28 ( PubMed/Corpus ); précédent : 002C27; suivant : 002C29

Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2 × 2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment.

Auteurs : Yining Huang ; Vijay K. Sharma ; Thompson Robinson ; Richard I. Lindley ; Xiaoying Chen ; Jong Sung Kim ; Pablo Lavados ; Ver Nica Olavarría ; Hisatomi Arima ; Sully Fuentes ; Huy Thang Nguyen ; Tsong-Hai Lee ; Mark W. Parsons ; Christopher Levi ; Andrew M. Demchuk ; Philip M W. Bath ; Joseph P. Broderick ; Geoffrey A. Donnan ; Sheila Martins ; Octavio M. Pontes-Neto ; Federico Silva ; Jeyaraj Pandian ; Stefano Ricci ; Christian Stapf ; Mark Woodward ; Jiguang Wang ; John Chalmers ; Craig S. Anderson

Source :

RBID : pubmed:25832995

English descriptors

Abstract

Controversy exists over the optimal dose of intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) and degree of blood pressure (BP) control in acute ischaemic stroke (AIS). Asian studies suggest low-dose (0·6 mg/kg) is more efficacious than standard-dose (0·9 mg/kg) i.v. rt-PA, and guidelines recommend reducing systolic BP to <185 mmHg before and <180 mmHg after use of i.v. rt-PA, despite observational studies indicating better outcomes at much lower (<140 mmHg) systolic BP levels in this patient group.

DOI: 10.1111/ijs.12486
PubMed: 25832995

Links to Exploration step

pubmed:25832995

Le document en format XML

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<name sortKey="Huang, Yining" sort="Huang, Yining" uniqKey="Huang Y" first="Yining" last="Huang">Yining Huang</name>
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<nlm:affiliation>Department of Neurology, Peking University First Hospital, Beijing, China.</nlm:affiliation>
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<name sortKey="Sharma, Vijay K" sort="Sharma, Vijay K" uniqKey="Sharma V" first="Vijay K" last="Sharma">Vijay K. Sharma</name>
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<nlm:affiliation>Division of Neurology, Department of Medicine, National University Hospital and YLL School of Medicine, National University of Singapore, Singapore.</nlm:affiliation>
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<name sortKey="Robinson, Thompson" sort="Robinson, Thompson" uniqKey="Robinson T" first="Thompson" last="Robinson">Thompson Robinson</name>
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<nlm:affiliation>Department of Cardiovascular Sciences and NIHR Biomedical Research Unit, University of Leicester University, Leicester, UK.</nlm:affiliation>
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<name sortKey="Lindley, Richard I" sort="Lindley, Richard I" uniqKey="Lindley R" first="Richard I" last="Lindley">Richard I. Lindley</name>
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<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
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<name sortKey="Chen, Xiaoying" sort="Chen, Xiaoying" uniqKey="Chen X" first="Xiaoying" last="Chen">Xiaoying Chen</name>
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<name sortKey="Kim, Jong Sung" sort="Kim, Jong Sung" uniqKey="Kim J" first="Jong Sung" last="Kim">Jong Sung Kim</name>
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<name sortKey="Lavados, Pablo" sort="Lavados, Pablo" uniqKey="Lavados P" first="Pablo" last="Lavados">Pablo Lavados</name>
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<name sortKey="Arima, Hisatomi" sort="Arima, Hisatomi" uniqKey="Arima H" first="Hisatomi" last="Arima">Hisatomi Arima</name>
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<name sortKey="Fuentes, Sully" sort="Fuentes, Sully" uniqKey="Fuentes S" first="Sully" last="Fuentes">Sully Fuentes</name>
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<name sortKey="Nguyen, Huy Thang" sort="Nguyen, Huy Thang" uniqKey="Nguyen H" first="Huy Thang" last="Nguyen">Huy Thang Nguyen</name>
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<name sortKey="Lee, Tsong Hai" sort="Lee, Tsong Hai" uniqKey="Lee T" first="Tsong-Hai" last="Lee">Tsong-Hai Lee</name>
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<name sortKey="Parsons, Mark W" sort="Parsons, Mark W" uniqKey="Parsons M" first="Mark W" last="Parsons">Mark W. Parsons</name>
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<nlm:affiliation>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.</nlm:affiliation>
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<name sortKey="Levi, Christopher" sort="Levi, Christopher" uniqKey="Levi C" first="Christopher" last="Levi">Christopher Levi</name>
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<nlm:affiliation>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.</nlm:affiliation>
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<name sortKey="Demchuk, Andrew M" sort="Demchuk, Andrew M" uniqKey="Demchuk A" first="Andrew M" last="Demchuk">Andrew M. Demchuk</name>
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<nlm:affiliation>Calgary Stroke Program, Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, Canada.</nlm:affiliation>
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<name sortKey="Bath, Philip M W" sort="Bath, Philip M W" uniqKey="Bath P" first="Philip M W" last="Bath">Philip M W. Bath</name>
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<name sortKey="Broderick, Joseph P" sort="Broderick, Joseph P" uniqKey="Broderick J" first="Joseph P" last="Broderick">Joseph P. Broderick</name>
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<nlm:affiliation>Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.</nlm:affiliation>
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<name sortKey="Donnan, Geoffrey A" sort="Donnan, Geoffrey A" uniqKey="Donnan G" first="Geoffrey A" last="Donnan">Geoffrey A. Donnan</name>
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<nlm:affiliation>The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia.</nlm:affiliation>
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<name sortKey="Martins, Sheila" sort="Martins, Sheila" uniqKey="Martins S" first="Sheila" last="Martins">Sheila Martins</name>
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<nlm:affiliation>Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio grande do Sul, Rio Grande do Sul, Brazil.</nlm:affiliation>
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<name sortKey="Pontes Neto, Octavio M" sort="Pontes Neto, Octavio M" uniqKey="Pontes Neto O" first="Octavio M" last="Pontes-Neto">Octavio M. Pontes-Neto</name>
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<nlm:affiliation>Stroke Service - Neurology Division, Department of Neuroscience and Behavior, Ribeirão Preto School of Medicine, University of Sao Paulo, Ribeirão Preto, SP, Brazil.</nlm:affiliation>
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<name sortKey="Silva, Federico" sort="Silva, Federico" uniqKey="Silva F" first="Federico" last="Silva">Federico Silva</name>
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<nlm:affiliation>Fundación Cardiovascular, Bucaramanga, Colombia.</nlm:affiliation>
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<name sortKey="Pandian, Jeyaraj" sort="Pandian, Jeyaraj" uniqKey="Pandian J" first="Jeyaraj" last="Pandian">Jeyaraj Pandian</name>
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<nlm:affiliation>Department of Neurology, Christian Medical College, Ludhiana, India.</nlm:affiliation>
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<name sortKey="Ricci, Stefano" sort="Ricci, Stefano" uniqKey="Ricci S" first="Stefano" last="Ricci">Stefano Ricci</name>
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<name sortKey="Stapf, Christian" sort="Stapf, Christian" uniqKey="Stapf C" first="Christian" last="Stapf">Christian Stapf</name>
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<nlm:affiliation>Department of Neurology, APHP - Hôpital Lariboisière and DHU NeuroVasc Paris - Sorbonne, Univ Paris Diderot - Sorbonne Paris Cité, Paris, France.</nlm:affiliation>
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<name sortKey="Woodward, Mark" sort="Woodward, Mark" uniqKey="Woodward M" first="Mark" last="Woodward">Mark Woodward</name>
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<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
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<name sortKey="Wang, Jiguang" sort="Wang, Jiguang" uniqKey="Wang J" first="Jiguang" last="Wang">Jiguang Wang</name>
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<nlm:affiliation>The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.</nlm:affiliation>
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<name sortKey="Chalmers, John" sort="Chalmers, John" uniqKey="Chalmers J" first="John" last="Chalmers">John Chalmers</name>
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<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
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<name sortKey="Anderson, Craig S" sort="Anderson, Craig S" uniqKey="Anderson C" first="Craig S" last="Anderson">Craig S. Anderson</name>
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<title xml:lang="en">Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2 × 2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment.</title>
<author>
<name sortKey="Huang, Yining" sort="Huang, Yining" uniqKey="Huang Y" first="Yining" last="Huang">Yining Huang</name>
<affiliation>
<nlm:affiliation>Department of Neurology, Peking University First Hospital, Beijing, China.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Sharma, Vijay K" sort="Sharma, Vijay K" uniqKey="Sharma V" first="Vijay K" last="Sharma">Vijay K. Sharma</name>
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<nlm:affiliation>Division of Neurology, Department of Medicine, National University Hospital and YLL School of Medicine, National University of Singapore, Singapore.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Robinson, Thompson" sort="Robinson, Thompson" uniqKey="Robinson T" first="Thompson" last="Robinson">Thompson Robinson</name>
<affiliation>
<nlm:affiliation>Department of Cardiovascular Sciences and NIHR Biomedical Research Unit, University of Leicester University, Leicester, UK.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Lindley, Richard I" sort="Lindley, Richard I" uniqKey="Lindley R" first="Richard I" last="Lindley">Richard I. Lindley</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Chen, Xiaoying" sort="Chen, Xiaoying" uniqKey="Chen X" first="Xiaoying" last="Chen">Xiaoying Chen</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Kim, Jong Sung" sort="Kim, Jong Sung" uniqKey="Kim J" first="Jong Sung" last="Kim">Jong Sung Kim</name>
<affiliation>
<nlm:affiliation>Asan Medical Center, University of Ulsan, Seoul, South Korea.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Lavados, Pablo" sort="Lavados, Pablo" uniqKey="Lavados P" first="Pablo" last="Lavados">Pablo Lavados</name>
<affiliation>
<nlm:affiliation>Clinica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Olavarria, Ver Nica" sort="Olavarria, Ver Nica" uniqKey="Olavarria V" first="Ver Nica" last="Olavarría">Ver Nica Olavarría</name>
<affiliation>
<nlm:affiliation>Clinica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Arima, Hisatomi" sort="Arima, Hisatomi" uniqKey="Arima H" first="Hisatomi" last="Arima">Hisatomi Arima</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Fuentes, Sully" sort="Fuentes, Sully" uniqKey="Fuentes S" first="Sully" last="Fuentes">Sully Fuentes</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Nguyen, Huy Thang" sort="Nguyen, Huy Thang" uniqKey="Nguyen H" first="Huy Thang" last="Nguyen">Huy Thang Nguyen</name>
<affiliation>
<nlm:affiliation>Stroke Unit, People's 115 Hospital, Ho Chi Minh City, Vietnam.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Lee, Tsong Hai" sort="Lee, Tsong Hai" uniqKey="Lee T" first="Tsong-Hai" last="Lee">Tsong-Hai Lee</name>
<affiliation>
<nlm:affiliation>Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Parsons, Mark W" sort="Parsons, Mark W" uniqKey="Parsons M" first="Mark W" last="Parsons">Mark W. Parsons</name>
<affiliation>
<nlm:affiliation>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Levi, Christopher" sort="Levi, Christopher" uniqKey="Levi C" first="Christopher" last="Levi">Christopher Levi</name>
<affiliation>
<nlm:affiliation>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Demchuk, Andrew M" sort="Demchuk, Andrew M" uniqKey="Demchuk A" first="Andrew M" last="Demchuk">Andrew M. Demchuk</name>
<affiliation>
<nlm:affiliation>Calgary Stroke Program, Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Bath, Philip M W" sort="Bath, Philip M W" uniqKey="Bath P" first="Philip M W" last="Bath">Philip M W. Bath</name>
<affiliation>
<nlm:affiliation>Stroke trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Broderick, Joseph P" sort="Broderick, Joseph P" uniqKey="Broderick J" first="Joseph P" last="Broderick">Joseph P. Broderick</name>
<affiliation>
<nlm:affiliation>Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.</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>The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Martins, Sheila" sort="Martins, Sheila" uniqKey="Martins S" first="Sheila" last="Martins">Sheila Martins</name>
<affiliation>
<nlm:affiliation>Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio grande do Sul, Rio Grande do Sul, Brazil.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Pontes Neto, Octavio M" sort="Pontes Neto, Octavio M" uniqKey="Pontes Neto O" first="Octavio M" last="Pontes-Neto">Octavio M. Pontes-Neto</name>
<affiliation>
<nlm:affiliation>Stroke Service - Neurology Division, Department of Neuroscience and Behavior, Ribeirão Preto School of Medicine, University of Sao Paulo, Ribeirão Preto, SP, Brazil.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Silva, Federico" sort="Silva, Federico" uniqKey="Silva F" first="Federico" last="Silva">Federico Silva</name>
<affiliation>
<nlm:affiliation>Fundación Cardiovascular, Bucaramanga, Colombia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Pandian, Jeyaraj" sort="Pandian, Jeyaraj" uniqKey="Pandian J" first="Jeyaraj" last="Pandian">Jeyaraj Pandian</name>
<affiliation>
<nlm:affiliation>Department of Neurology, Christian Medical College, Ludhiana, India.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Ricci, Stefano" sort="Ricci, Stefano" uniqKey="Ricci S" first="Stefano" last="Ricci">Stefano Ricci</name>
<affiliation>
<nlm:affiliation>Direttore, UO Neurologia, USL Umbria 1, Sedi di Città di Castello e Branca, Italy.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Stapf, Christian" sort="Stapf, Christian" uniqKey="Stapf C" first="Christian" last="Stapf">Christian Stapf</name>
<affiliation>
<nlm:affiliation>Department of Neurology, APHP - Hôpital Lariboisière and DHU NeuroVasc Paris - Sorbonne, Univ Paris Diderot - Sorbonne Paris Cité, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Woodward, Mark" sort="Woodward, Mark" uniqKey="Woodward M" first="Mark" last="Woodward">Mark Woodward</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Wang, Jiguang" sort="Wang, Jiguang" uniqKey="Wang J" first="Jiguang" last="Wang">Jiguang Wang</name>
<affiliation>
<nlm:affiliation>The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Chalmers, John" sort="Chalmers, John" uniqKey="Chalmers J" first="John" last="Chalmers">John Chalmers</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Anderson, Craig S" sort="Anderson, Craig S" uniqKey="Anderson C" first="Craig S" last="Anderson">Craig S. Anderson</name>
<affiliation>
<nlm:affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</nlm:affiliation>
</affiliation>
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<title level="j">International journal of stroke : official journal of the International Stroke Society</title>
<idno type="eISSN">1747-4949</idno>
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<term>Brain Ischemia (complications)</term>
<term>Female</term>
<term>Fibrinolytic Agents (therapeutic use)</term>
<term>Humans</term>
<term>International Cooperation</term>
<term>Male</term>
<term>Stroke (drug therapy)</term>
<term>Stroke (etiology)</term>
<term>Tissue Plasminogen Activator (therapeutic use)</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Fibrinolytic Agents</term>
<term>Tissue Plasminogen Activator</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en">
<term>Brain Ischemia</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Stroke</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en">
<term>Stroke</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Female</term>
<term>Humans</term>
<term>International Cooperation</term>
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<term>Treatment Outcome</term>
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<div type="abstract" xml:lang="en">Controversy exists over the optimal dose of intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) and degree of blood pressure (BP) control in acute ischaemic stroke (AIS). Asian studies suggest low-dose (0·6 mg/kg) is more efficacious than standard-dose (0·9 mg/kg) i.v. rt-PA, and guidelines recommend reducing systolic BP to <185 mmHg before and <180 mmHg after use of i.v. rt-PA, despite observational studies indicating better outcomes at much lower (<140 mmHg) systolic BP levels in this patient group.</div>
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<Day>22</Day>
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<Day>22</Day>
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<Title>International journal of stroke : official journal of the International Stroke Society</Title>
<ISOAbbreviation>Int J Stroke</ISOAbbreviation>
</Journal>
<ArticleTitle>Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2 × 2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment.</ArticleTitle>
<Pagination>
<MedlinePgn>778-88</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1111/ijs.12486</ELocationID>
<Abstract>
<AbstractText Label="RATIONALE" NlmCategory="BACKGROUND">Controversy exists over the optimal dose of intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) and degree of blood pressure (BP) control in acute ischaemic stroke (AIS). Asian studies suggest low-dose (0·6 mg/kg) is more efficacious than standard-dose (0·9 mg/kg) i.v. rt-PA, and guidelines recommend reducing systolic BP to <185 mmHg before and <180 mmHg after use of i.v. rt-PA, despite observational studies indicating better outcomes at much lower (<140 mmHg) systolic BP levels in this patient group.</AbstractText>
<AbstractText Label="AIMS" NlmCategory="OBJECTIVE">The study aims to assess in thrombolysis-eligible AIS patients whether: (i) low-dose (0·6 mg/kg body weight; maximum 60 mg) i.v. rt-PA has non-inferior efficacy and lower risk of symptomatic intracerebral haemorrhage (sICH) compared to standard-dose (0·9 mg/kg body weight; maximum 90 mg) i.v. rt-PA; and (ii) early intensive BP lowering (systolic target 130-140 mmHg) has superior efficacy and lower risk of any ICH compared to guideline-recommended BP control (systolic target < 180 mmHg).</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">The ENhanced Control of Hypertension And Thrombolysis strokE stuDy (ENCHANTED) trial is an independent,2 × 2 quasi-factorial, active-comparison, prospective, randomized, open blinded endpoint (PROBE), clinical trial that is evaluating Arm [A] 'rt-PA dose' and/or Arm [B] 'BP control', using central Internet randomization and data collection in patients fulfilling local criteria for thrombolysis and clinician uncertainty over the study treatments. The treatment arms will be analyzed separately.</AbstractText>
<AbstractText Label="STUDY OUTCOMES" NlmCategory="RESULTS">The primary study outcome in both trial Arms is death or disability according to the modified Rankin scale (mRS, scores 2-6) assessed at 90 days. Secondary outcomes include sICH, any ICH, a shift ('improvement') in function across mRS scores, separately on death and disability, early neurological deterioration, recurrent major vascular events, health-related quality of life, length of hospital stay, need for permanent residential care, and health care costs.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Following launch of the trial in February 2012, the study has recruited more than 2500 patients across a global network of approximately 100 sites in 15 countries. The required sample sizes are 3300 for Arm [A] and 2300 for Arm [B], which will provide >90% power to detect non-inferiority of low-dose i.v. rt-PA and superiority of intensive BP lowering on the primary clinical outcome, respectively.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Low-dose i.v. rt-PA and early intensive BP lowering could provide more affordable and safer use of thrombolysis treatment for patients with AIS worldwide.</AbstractText>
<CopyrightInformation>© 2015 World Stroke Organization.</CopyrightInformation>
</Abstract>
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<LastName>Huang</LastName>
<ForeName>Yining</ForeName>
<Initials>Y</Initials>
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<Affiliation>Department of Neurology, Peking University First Hospital, Beijing, China.</Affiliation>
</AffiliationInfo>
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<ForeName>Vijay K</ForeName>
<Initials>VK</Initials>
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<Affiliation>Division of Neurology, Department of Medicine, National University Hospital and YLL School of Medicine, National University of Singapore, Singapore.</Affiliation>
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<ForeName>Thompson</ForeName>
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<Affiliation>Department of Cardiovascular Sciences and NIHR Biomedical Research Unit, University of Leicester University, Leicester, UK.</Affiliation>
</AffiliationInfo>
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<LastName>Lindley</LastName>
<ForeName>Richard I</ForeName>
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<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
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<LastName>Chen</LastName>
<ForeName>Xiaoying</ForeName>
<Initials>X</Initials>
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<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
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<LastName>Kim</LastName>
<ForeName>Jong Sung</ForeName>
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<Affiliation>Asan Medical Center, University of Ulsan, Seoul, South Korea.</Affiliation>
</AffiliationInfo>
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<LastName>Lavados</LastName>
<ForeName>Pablo</ForeName>
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<AffiliationInfo>
<Affiliation>Clinica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Universidad de Chile, Santiago, Chile.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Olavarría</LastName>
<ForeName>Verónica</ForeName>
<Initials>V</Initials>
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</Author>
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<LastName>Arima</LastName>
<ForeName>Hisatomi</ForeName>
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<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
</AffiliationInfo>
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<LastName>Fuentes</LastName>
<ForeName>Sully</ForeName>
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<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
</AffiliationInfo>
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<LastName>Nguyen</LastName>
<ForeName>Huy Thang</ForeName>
<Initials>HT</Initials>
<AffiliationInfo>
<Affiliation>Stroke Unit, People's 115 Hospital, Ho Chi Minh City, Vietnam.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Lee</LastName>
<ForeName>Tsong-Hai</ForeName>
<Initials>TH</Initials>
<AffiliationInfo>
<Affiliation>Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Parsons</LastName>
<ForeName>Mark W</ForeName>
<Initials>MW</Initials>
<AffiliationInfo>
<Affiliation>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Levi</LastName>
<ForeName>Christopher</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Demchuk</LastName>
<ForeName>Andrew M</ForeName>
<Initials>AM</Initials>
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<Affiliation>Calgary Stroke Program, Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bath</LastName>
<ForeName>Philip M W</ForeName>
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<Affiliation>Stroke trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Broderick</LastName>
<ForeName>Joseph P</ForeName>
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<Affiliation>Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y">
<LastName>Donnan</LastName>
<ForeName>Geoffrey A</ForeName>
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<Affiliation>The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia.</Affiliation>
</AffiliationInfo>
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<LastName>Martins</LastName>
<ForeName>Sheila</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio grande do Sul, Rio Grande do Sul, Brazil.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y">
<LastName>Pontes-Neto</LastName>
<ForeName>Octavio M</ForeName>
<Initials>OM</Initials>
<AffiliationInfo>
<Affiliation>Stroke Service - Neurology Division, Department of Neuroscience and Behavior, Ribeirão Preto School of Medicine, University of Sao Paulo, Ribeirão Preto, SP, Brazil.</Affiliation>
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</Author>
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<LastName>Silva</LastName>
<ForeName>Federico</ForeName>
<Initials>F</Initials>
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<Affiliation>Fundación Cardiovascular, Bucaramanga, Colombia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pandian</LastName>
<ForeName>Jeyaraj</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Department of Neurology, Christian Medical College, Ludhiana, India.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ricci</LastName>
<ForeName>Stefano</ForeName>
<Initials>S</Initials>
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<Affiliation>Direttore, UO Neurologia, USL Umbria 1, Sedi di Città di Castello e Branca, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Stapf</LastName>
<ForeName>Christian</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Department of Neurology, APHP - Hôpital Lariboisière and DHU NeuroVasc Paris - Sorbonne, Univ Paris Diderot - Sorbonne Paris Cité, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Woodward</LastName>
<ForeName>Mark</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
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<LastName>Wang</LastName>
<ForeName>Jiguang</ForeName>
<Initials>J</Initials>
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<Affiliation>The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.</Affiliation>
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<LastName>Chalmers</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
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<LastName>Anderson</LastName>
<ForeName>Craig S</ForeName>
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<AffiliationInfo>
<Affiliation>The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.</Affiliation>
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<CollectiveName>ENCHANTED investigators</CollectiveName>
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<Keyword MajorTopicYN="N">dose</Keyword>
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<Keyword MajorTopicYN="N">rt-PA</Keyword>
<Keyword MajorTopicYN="N">thrombolysis</Keyword>
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<Month>12</Month>
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