Effect of Clopidogrel on the Rate and Functional Severity of Stroke Among High Vascular Risk Patients: A Prespecified Substudy of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Trial
Identifieur interne : 007923 ( Main/Exploration ); précédent : 007922; suivant : 007924Effect of Clopidogrel on the Rate and Functional Severity of Stroke Among High Vascular Risk Patients: A Prespecified Substudy of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Trial
Auteurs : Graeme J. Hankey [Australie] ; Werner Hacke [Allemagne] ; J. Donald Easton [États-Unis] ; S. Claiborne Johnston [États-Unis] ; Jean-Louis Mas [France] ; Danielle M. Brennan [États-Unis] ; Deepak L. Bhatt [États-Unis] ; Keith A. A. Fox [Royaume-Uni] ; Eric J. Topol [États-Unis]Source :
- Stroke : (1970) [ 0039-2499 ] ; 2010.
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- topic : Homme.
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Abstract
Background and Purpose-Disabling stroke is costly and considered by some patients a fate worse than death. We aimed to determine whether clopidogrel reduces the rate and functional severity of stroke among high vascular risk patients, including patients with previous transient ischemic attack or ischemic stroke, who were enrolled in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial. Methods-We randomly assigned 15 603 high vascular risk patients to receive clopidogrel (75 mg daily) or placebo in addition to background acetylsalicylic acid and followed them for a median of 28 months. The main outcome of this prespecified substudy was the functional severity of stroke outcome events as measured by the modified Rankin Scale (mRS) score at 3 months after the stroke outcome. Results-During follow-up, 436 (2.8%) patients had a definite adjudicated stroke and a follow-up assessment of the mRS at 3 months poststroke, of whom 202 had been randomly assigned clopidogrel and 234 placebo (relative risk reduction 14%, 95% CI: -4% to 29%, P=0.12). There was no significant difference between the mean mRS scores at 3 months after stroke among patients assigned clopidogrel compared with placebo (mean mRS 3.6 [SD 2.4] clopidogrel versus 3.3 [SD 2.1] placebo; P=0.15). There was also no significant difference between the various categories of the mRS score at 3 months after stroke among patients assigned to clopidogrel compared with placebo. Among 4320 patients with a qualifying diagnosis of transient ischemic attack or ischemic stroke, 233 (5.4%) experienced a stroke during follow-up, of whom 103 were randomly assigned clopidogrel and 130 placebo (relative risk reduction 20%, 95% CI: -3% to 38%). There was no significant difference between the mean mRS scores at 3 months after stroke among patients with a qualifying transient ischemic attack or ischemic stroke who were assigned clopidogrel compared with placebo (3.4 [SD 2.1] clopidogrel versus 3.3 [SD 1.9] placebo; P=0.48). Conclusion-The addition of clopidogrel to acetylsalicylic acid did not significantly alter the rate and functional severity of stroke outcome events among high vascular risk patients enrolled in the CHARISMA trial.
Affiliations:
- Allemagne, Australie, France, Royaume-Uni, États-Unis
- Bade-Wurtemberg, District de Karlsruhe, Ohio, Rhode Island, Écosse, Île-de-France
- Heidelberg, Paris, Providence (Rhode Island), Édimbourg
- Université Brown
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Hankey</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Neurology Department Royal Perth Hospital</s1><s2>Perth</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Neurology Department Royal Perth Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Neurology Department Im Neuenheimer Feld 400</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Easton, J Donald" sort="Easton, J Donald" uniqKey="Easton J" first="J. Donald" last="Easton">J. Donald Easton</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Brown University</s1><s2>Providence, RI</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Providence (Rhode Island)</settlement><region type="state">Rhode Island</region></placeName><orgName type="university">Université Brown</orgName></affiliation></author><author><name sortKey="Johnston, S Claiborne" sort="Johnston, S Claiborne" uniqKey="Johnston S" first="S. Claiborne" last="Johnston">S. Claiborne Johnston</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>UCSF Neurology</s1><s2>San Francisco, Calif</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>UCSF Neurology</wicri:noRegion></affiliation></author><author><name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Service de Neurologie (J.-L.M.), Hôpital Sainte-Anne</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M." last="Brennan">Danielle M. 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Fox</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>University and Royal Infirmary of Edinburgh</s1><s2>Edinburgh</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J." last="Topol">Eric J. Topol</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Scripps Health and Scripps Translational Science Institute</s1><s2>La Jolla, Calif</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Scripps Health and Scripps Translational Science Institute</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0388819</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 10-0388819 INIST</idno><idno type="RBID">Pascal:10-0388819</idno><idno type="wicri:Area/PascalFrancis/Corpus">002441</idno><idno type="wicri:Area/PascalFrancis/Curation">003B47</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002473</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002473</idno><idno type="wicri:doubleKey">0039-2499:2010:Hankey G:effect:of:clopidogrel</idno><idno type="wicri:Area/Main/Merge">007F41</idno><idno type="wicri:Area/Main/Curation">007923</idno><idno type="wicri:Area/Main/Exploration">007923</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Effect of Clopidogrel on the Rate and Functional Severity of Stroke Among High Vascular Risk Patients: A Prespecified Substudy of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Trial</title><author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Neurology Department Royal Perth Hospital</s1><s2>Perth</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Neurology Department Royal Perth Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Neurology Department Im Neuenheimer Feld 400</s1><s2>Heidelberg</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Easton, J Donald" sort="Easton, J Donald" uniqKey="Easton J" first="J. Donald" last="Easton">J. Donald Easton</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Brown University</s1><s2>Providence, RI</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Providence (Rhode Island)</settlement><region type="state">Rhode Island</region></placeName><orgName type="university">Université Brown</orgName></affiliation></author><author><name sortKey="Johnston, S Claiborne" sort="Johnston, S Claiborne" uniqKey="Johnston S" first="S. Claiborne" last="Johnston">S. Claiborne Johnston</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>UCSF Neurology</s1><s2>San Francisco, Calif</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>UCSF Neurology</wicri:noRegion></affiliation></author><author><name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Service de Neurologie (J.-L.M.), Hôpital Sainte-Anne</s1><s2>Paris</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M." last="Brennan">Danielle M. Brennan</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Cleveland Clinic</s1><s2>Cleveland, Ohio</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Bhatt, Deepak L" sort="Bhatt, Deepak L" uniqKey="Bhatt D" first="Deepak L." last="Bhatt">Deepak L. Bhatt</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>VA Boston Healthcare System Brigham and Women's Hospital, and Harvard Medical School</s1><s2>Boston, Mass</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, Mass</wicri:noRegion></affiliation></author><author><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>University and Royal Infirmary of Edinburgh</s1><s2>Edinburgh</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Édimbourg</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J." last="Topol">Eric J. Topol</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Scripps Health and Scripps Translational Science Institute</s1><s2>La Jolla, Calif</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Scripps Health and Scripps Translational Science Institute</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Stroke : (1970)</title><title level="j" type="abbreviated">Stroke : (1970)</title><idno type="ISSN">0039-2499</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Stroke : (1970)</title><title level="j" type="abbreviated">Stroke : (1970)</title><idno type="ISSN">0039-2499</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiplatelet agent</term><term>Antithrombotic agent</term><term>Cerebrovascular disease</term><term>Clinical management</term><term>Clopidogrel</term><term>Human</term><term>Infarct</term><term>Ischemia</term><term>Nervous system diseases</term><term>Prevention</term><term>Risk factor</term><term>Stroke</term><term>Thrombosis</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Accident cérébrovasculaire</term><term>Thrombose</term><term>Ischémie</term><term>Pathologie cérébrovasculaire</term><term>Pathologie du système nerveux</term><term>Clopidogrel</term><term>Facteur risque</term><term>Homme</term><term>Conduite à tenir</term><term>Traitement</term><term>Infarctus</term><term>Prévention</term><term>Antithrombotique</term><term>Inhibiteur thromboagrégation</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background and Purpose-Disabling stroke is costly and considered by some patients a fate worse than death. We aimed to determine whether clopidogrel reduces the rate and functional severity of stroke among high vascular risk patients, including patients with previous transient ischemic attack or ischemic stroke, who were enrolled in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial. Methods-We randomly assigned 15 603 high vascular risk patients to receive clopidogrel (75 mg daily) or placebo in addition to background acetylsalicylic acid and followed them for a median of 28 months. The main outcome of this prespecified substudy was the functional severity of stroke outcome events as measured by the modified Rankin Scale (mRS) score at 3 months after the stroke outcome. Results-During follow-up, 436 (2.8%) patients had a definite adjudicated stroke and a follow-up assessment of the mRS at 3 months poststroke, of whom 202 had been randomly assigned clopidogrel and 234 placebo (relative risk reduction 14%, 95% CI: -4% to 29%, P=0.12). There was no significant difference between the mean mRS scores at 3 months after stroke among patients assigned clopidogrel compared with placebo (mean mRS 3.6 [SD 2.4] clopidogrel versus 3.3 [SD 2.1] placebo; P=0.15). There was also no significant difference between the various categories of the mRS score at 3 months after stroke among patients assigned to clopidogrel compared with placebo. Among 4320 patients with a qualifying diagnosis of transient ischemic attack or ischemic stroke, 233 (5.4%) experienced a stroke during follow-up, of whom 103 were randomly assigned clopidogrel and 130 placebo (relative risk reduction 20%, 95% CI: -3% to 38%). There was no significant difference between the mean mRS scores at 3 months after stroke among patients with a qualifying transient ischemic attack or ischemic stroke who were assigned clopidogrel compared with placebo (3.4 [SD 2.1] clopidogrel versus 3.3 [SD 1.9] placebo; P=0.48). Conclusion-The addition of clopidogrel to acetylsalicylic acid did not significantly alter the rate and functional severity of stroke outcome events among high vascular risk patients enrolled in the CHARISMA trial.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Bade-Wurtemberg</li><li>District de Karlsruhe</li><li>Ohio</li><li>Rhode Island</li><li>Écosse</li><li>Île-de-France</li></region><settlement><li>Heidelberg</li><li>Paris</li><li>Providence (Rhode Island)</li><li>Édimbourg</li></settlement><orgName><li>Université Brown</li></orgName></list><tree><country name="Australie"><noRegion><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name></noRegion></country><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Hacke, Werner" sort="Hacke, Werner" uniqKey="Hacke W" first="Werner" last="Hacke">Werner Hacke</name></region></country><country name="États-Unis"><region name="Rhode Island"><name sortKey="Easton, J Donald" sort="Easton, J Donald" uniqKey="Easton J" first="J. Donald" last="Easton">J. Donald Easton</name></region><name sortKey="Bhatt, Deepak L" sort="Bhatt, Deepak L" uniqKey="Bhatt D" first="Deepak L." last="Bhatt">Deepak L. Bhatt</name><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M." last="Brennan">Danielle M. Brennan</name><name sortKey="Johnston, S Claiborne" sort="Johnston, S Claiborne" uniqKey="Johnston S" first="S. Claiborne" last="Johnston">S. Claiborne Johnston</name><name sortKey="Topol, Eric J" sort="Topol, Eric J" uniqKey="Topol E" first="Eric J." last="Topol">Eric J. Topol</name></country><country name="France"><region name="Île-de-France"><name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name></region></country><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Fox, Keith A A" sort="Fox, Keith A A" uniqKey="Fox K" first="Keith A. A." last="Fox">Keith A. A. Fox</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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