Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques
Identifieur interne : 004246 ( Main/Exploration ); précédent : 004245; suivant : 004247Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques
Auteurs : Pierre Amarenco [France] ; Stephen Davis [Australie] ; Elizabeth F. Jones [Australie] ; Ariel A. Cohen [France] ; Wolf-Dieter Heiss [Allemagne] ; Markku Kaste [Finlande] ; Cédric Laouenan [France] ; Dennis Young [Australie] ; Malcolm Macleod [Australie, Royaume-Uni] ; Geoffrey A. Donnan [Australie]Source :
- Stroke : (1970) [ 0039-2499 ] ; 2014.
Descripteurs français
- Pascal (Inist)
- Accident cérébrovasculaire, Athérosclérose, Ramollissement cérébral, Clopidogrel, Acide acétylsalicylique, Warfarine, Etude comparative, Homme, Arc aortique, Aorte, Pathologie du système nerveux, Pathologie cérébrovasculaire, Antithrombotique, Inhibiteur thromboagrégation, Antipyrétique, Analgésique, Antiinflammatoire non stéroïde, Anticoagulant.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Acetylsalicylic acid, Analgesic, Anticoagulant, Antiplatelet agent, Antipyretic, Antithrombotic agent, Aorta, Aortic arch, Atherosclerosis, Cerebral infarction, Cerebrovascular disease, Clopidogrel, Comparative study, Human, Nervous system diseases, Non steroidal antiinflammatory agent, Stroke, Warfarin.
Abstract
Background and Purpose-Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. Methods-This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta >4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization. Results-The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups. Conclusions-Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating.
Affiliations:
- Allemagne, Australie, Finlande, France, Royaume-Uni
- Uusimaa, Victoria (État), Écosse, Île-de-France
- Helsinki, Melbourne, Paris, Édimbourg
- Université d'Helsinki, Université d'Édimbourg, Université de Melbourne
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 000375
- to stream PascalFrancis, to step Curation: 005A87
- to stream PascalFrancis, to step Checkpoint: 000393
- to stream Main, to step Merge: 004317
- to stream Main, to step Curation: 004246
Le document en format XML
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<author><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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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques</title>
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<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Stroke Centre, DHU FIRE, INSERM U 1148, Paris Diderot-Sorbonne University, Hôpital Bichat</s1>
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<author><name sortKey="Davis, Stephen" sort="Davis, Stephen" uniqKey="Davis S" first="Stephen" last="Davis">Stephen Davis</name>
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<author><name sortKey="Heiss, Wolf Dieter" sort="Heiss, Wolf Dieter" uniqKey="Heiss W" first="Wolf-Dieter" last="Heiss">Wolf-Dieter Heiss</name>
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<author><name sortKey="Kaste, Markku" sort="Kaste, Markku" uniqKey="Kaste M" first="Markku" last="Kaste">Markku Kaste</name>
<affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Department of Neurology, Helsinki University Central Hospital, University of Helsinki</s1>
<s2>Helsinki</s2>
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<author><name sortKey="Laouenan, Cedric" sort="Laouenan, Cedric" uniqKey="Laouenan C" first="Cédric" last="Laouenan">Cédric Laouenan</name>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Biostatistics, Paris-Diderot-Sorbonne University, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>7 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>
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<author><name sortKey="Young, Dennis" sort="Young, Dennis" uniqKey="Young D" first="Dennis" last="Young">Dennis Young</name>
<affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Florey Institute of Neuroscience and Mental Health, University of Melbourne</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
<settlement type="city">Melbourne</settlement>
</placeName>
<orgName type="university">Université de Melbourne</orgName>
</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Stroke and Ageing Research Centre, Monash University</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
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<author><name sortKey="Macleod, Malcolm" sort="Macleod, Malcolm" uniqKey="Macleod M" first="Malcolm" last="Macleod">Malcolm Macleod</name>
<affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Florey Institute of Neuroscience and Mental Health, University of Melbourne</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
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<sZ>9 aut.</sZ>
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<region type="état">Victoria (État)</region>
<settlement type="city">Melbourne</settlement>
</placeName>
<orgName type="university">Université de Melbourne</orgName>
</affiliation>
<affiliation wicri:level="4"><inist:fA14 i1="10"><s1>Division of Clinical Neurosciences, University of Edinburgh (SC005336)</s1>
<s2>Scotland</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName><settlement type="city">Édimbourg</settlement>
<region type="country">Écosse</region>
</placeName>
<orgName type="university">Université d'Édimbourg</orgName>
</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 wicri:level="4"><inist:fA14 i1="05"><s1>Florey Institute of Neuroscience and Mental Health, University of Melbourne</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
<settlement type="city">Melbourne</settlement>
</placeName>
<orgName type="university">Université de Melbourne</orgName>
</affiliation>
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<series><title level="j" type="main">Stroke : (1970)</title>
<title level="j" type="abbreviated">Stroke : (1970)</title>
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<seriesStmt><title level="j" type="main">Stroke : (1970)</title>
<title level="j" type="abbreviated">Stroke : (1970)</title>
<idno type="ISSN">0039-2499</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acetylsalicylic acid</term>
<term>Analgesic</term>
<term>Anticoagulant</term>
<term>Antiplatelet agent</term>
<term>Antipyretic</term>
<term>Antithrombotic agent</term>
<term>Aorta</term>
<term>Aortic arch</term>
<term>Atherosclerosis</term>
<term>Cerebral infarction</term>
<term>Cerebrovascular disease</term>
<term>Clopidogrel</term>
<term>Comparative study</term>
<term>Human</term>
<term>Nervous system diseases</term>
<term>Non steroidal antiinflammatory agent</term>
<term>Stroke</term>
<term>Warfarin</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Accident cérébrovasculaire</term>
<term>Athérosclérose</term>
<term>Ramollissement cérébral</term>
<term>Clopidogrel</term>
<term>Acide acétylsalicylique</term>
<term>Warfarine</term>
<term>Etude comparative</term>
<term>Homme</term>
<term>Arc aortique</term>
<term>Aorte</term>
<term>Pathologie du système nerveux</term>
<term>Pathologie cérébrovasculaire</term>
<term>Antithrombotique</term>
<term>Inhibiteur thromboagrégation</term>
<term>Antipyrétique</term>
<term>Analgésique</term>
<term>Antiinflammatoire non stéroïde</term>
<term>Anticoagulant</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">Background and Purpose-Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. Methods-This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta >4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization. Results-The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups. Conclusions-Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Finlande</li>
<li>France</li>
<li>Royaume-Uni</li>
</country>
<region><li>Uusimaa</li>
<li>Victoria (État)</li>
<li>Écosse</li>
<li>Île-de-France</li>
</region>
<settlement><li>Helsinki</li>
<li>Melbourne</li>
<li>Paris</li>
<li>Édimbourg</li>
</settlement>
<orgName><li>Université d'Helsinki</li>
<li>Université d'Édimbourg</li>
<li>Université de Melbourne</li>
</orgName>
</list>
<tree><country name="France"><noRegion><name sortKey="Amarenco, Pierre" sort="Amarenco, Pierre" uniqKey="Amarenco P" first="Pierre" last="Amarenco">Pierre Amarenco</name>
</noRegion>
<name sortKey="Cohen, Ariel A" sort="Cohen, Ariel A" uniqKey="Cohen A" first="Ariel A." last="Cohen">Ariel A. Cohen</name>
<name sortKey="Laouenan, Cedric" sort="Laouenan, Cedric" uniqKey="Laouenan C" first="Cédric" last="Laouenan">Cédric Laouenan</name>
</country>
<country name="Australie"><noRegion><name sortKey="Davis, Stephen" sort="Davis, Stephen" uniqKey="Davis S" first="Stephen" last="Davis">Stephen Davis</name>
</noRegion>
<name sortKey="Donnan, Geoffrey A" sort="Donnan, Geoffrey A" uniqKey="Donnan G" first="Geoffrey A." last="Donnan">Geoffrey A. Donnan</name>
<name sortKey="Jones, Elizabeth F" sort="Jones, Elizabeth F" uniqKey="Jones E" first="Elizabeth F." last="Jones">Elizabeth F. Jones</name>
<name sortKey="Macleod, Malcolm" sort="Macleod, Malcolm" uniqKey="Macleod M" first="Malcolm" last="Macleod">Malcolm Macleod</name>
<name sortKey="Young, Dennis" sort="Young, Dennis" uniqKey="Young D" first="Dennis" last="Young">Dennis Young</name>
<name sortKey="Young, Dennis" sort="Young, Dennis" uniqKey="Young D" first="Dennis" last="Young">Dennis Young</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="Heiss, Wolf Dieter" sort="Heiss, Wolf Dieter" uniqKey="Heiss W" first="Wolf-Dieter" last="Heiss">Wolf-Dieter Heiss</name>
</noRegion>
</country>
<country name="Finlande"><region name="Uusimaa"><name sortKey="Kaste, Markku" sort="Kaste, Markku" uniqKey="Kaste M" first="Markku" last="Kaste">Markku Kaste</name>
</region>
</country>
<country name="Royaume-Uni"><region name="Écosse"><name sortKey="Macleod, Malcolm" sort="Macleod, Malcolm" uniqKey="Macleod M" first="Malcolm" last="Macleod">Malcolm Macleod</name>
</region>
</country>
</tree>
</affiliations>
</record>
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