Rationale and Design of the EPISTEME Trial: Efficacy of Post-Stroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke
Identifieur interne : 000104 ( Main/Exploration ); précédent : 000103; suivant : 000105Rationale and Design of the EPISTEME Trial: Efficacy of Post-Stroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke
Auteurs : Yuji Ueno [Japon] ; Kazuo Yamashiro [Japon] ; Yasutaka Tanaka [Japon] ; Masao Watanabe [Japon] ; Yoshiaki Shimada [Japon] ; Takuma Kuroki [Japon] ; Nobukazu Miyamoto [Japon] ; Masao Daimon [Japon] ; Ryota Tanaka [Japon] ; Katsumi Miyauchi [Japon] ; Hiroyuki Daida [Japon] ; Nobutaka Hattori [Japon] ; Takao Urabe [Japon]Source :
- Cardiovascular drugs and therapy [ 0920-3206 ] ; 2014.
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Abstract
Background Large atheromatous aortic plaques (AAPs) are associated with stroke recurrence. Rosuvastatin is a potent lipid-lowering agent and suppresses carotid and coronary artery atherosclerosis. It is unclear whether rosuvastatin has antiatherogenic effects against AAPs in stroke patients. We designed a clinical trial in stroke patients to analyze changes in AAPs after rosuvastatin treatment using repeated transesophageal echocardiography (TEE). Methods This trial is a prospective randomized open label study. Inclusion criteria were patients were ischemic stroke with hypercholesterolemia and AAPs >4 mm in thickness. The patients are randomly assigned to either a group treated with 5 mg/day rosuvastatin or a control group. Primary endpoint is the changes in volume and composition of AAPs after 6 months using transesophageal echocardiography (TEE). Biochemical findings are analyzed. By using repeated TEE and binary image analysis, we will be able to compare the dynamic changes in plaque composition of AAPs before and after therapy in the two groups. Conclusions The EPISTEME trial will provide information on the changes in plaque volume and composition achieved by improvement of lipid profiles with rosuvastatin therapy in stroke patients with aortic atherosclerosis. The results of the study may provide evidence for a therapeutic strategy for aortogenic brain embolism. This study is registered with UMIN-CTR (UMIN000010548).
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Rationale and Design of the EPISTEME Trial: Efficacy of Post-Stroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke</title><author><name sortKey="Ueno, Yuji" sort="Ueno, Yuji" uniqKey="Ueno Y" first="Yuji" last="Ueno">Yuji Ueno</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Yamashiro, Kazuo" sort="Yamashiro, Kazuo" uniqKey="Yamashiro K" first="Kazuo" last="Yamashiro">Kazuo Yamashiro</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 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2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Shimada, Yoshiaki" sort="Shimada, Yoshiaki" uniqKey="Shimada Y" first="Yoshiaki" last="Shimada">Yoshiaki Shimada</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Kuroki, Takuma" sort="Kuroki, Takuma" uniqKey="Kuroki T" first="Takuma" last="Kuroki">Takuma Kuroki</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Miyamoto, Nobukazu" sort="Miyamoto, Nobukazu" uniqKey="Miyamoto N" first="Nobukazu" last="Miyamoto">Nobukazu Miyamoto</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Daimon, Masao" sort="Daimon, Masao" uniqKey="Daimon M" first="Masao" last="Daimon">Masao Daimon</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Cardiology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Tanaka, Ryota" sort="Tanaka, Ryota" uniqKey="Tanaka R" first="Ryota" last="Tanaka">Ryota Tanaka</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Miyauchi, Katsumi" sort="Miyauchi, Katsumi" uniqKey="Miyauchi K" first="Katsumi" last="Miyauchi">Katsumi Miyauchi</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Cardiology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Daida, Hiroyuki" sort="Daida, Hiroyuki" uniqKey="Daida H" first="Hiroyuki" last="Daida">Hiroyuki Daida</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Cardiology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Hattori, Nobutaka" sort="Hattori, Nobutaka" uniqKey="Hattori N" first="Nobutaka" last="Hattori">Nobutaka 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Ueno</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Yamashiro, Kazuo" sort="Yamashiro, Kazuo" uniqKey="Yamashiro K" first="Kazuo" last="Yamashiro">Kazuo Yamashiro</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Tanaka, Yasutaka" sort="Tanaka, Yasutaka" uniqKey="Tanaka Y" first="Yasutaka" last="Tanaka">Yasutaka Tanaka</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Watanabe, Masao" sort="Watanabe, Masao" uniqKey="Watanabe M" first="Masao" last="Watanabe">Masao Watanabe</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Shimada, Yoshiaki" sort="Shimada, Yoshiaki" uniqKey="Shimada Y" first="Yoshiaki" last="Shimada">Yoshiaki Shimada</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Kuroki, Takuma" sort="Kuroki, Takuma" uniqKey="Kuroki T" first="Takuma" last="Kuroki">Takuma Kuroki</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Miyamoto, Nobukazu" sort="Miyamoto, Nobukazu" uniqKey="Miyamoto N" first="Nobukazu" last="Miyamoto">Nobukazu Miyamoto</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author><author><name sortKey="Daimon, Masao" sort="Daimon, Masao" uniqKey="Daimon M" first="Masao" last="Daimon">Masao Daimon</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Cardiology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Tanaka, Ryota" sort="Tanaka, Ryota" uniqKey="Tanaka R" first="Ryota" last="Tanaka">Ryota Tanaka</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Miyauchi, Katsumi" sort="Miyauchi, Katsumi" uniqKey="Miyauchi K" first="Katsumi" last="Miyauchi">Katsumi Miyauchi</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Cardiology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Daida, Hiroyuki" sort="Daida, Hiroyuki" uniqKey="Daida H" first="Hiroyuki" last="Daida">Hiroyuki Daida</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Cardiology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Hattori, Nobutaka" sort="Hattori, Nobutaka" uniqKey="Hattori N" first="Nobutaka" last="Hattori">Nobutaka Hattori</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Neurology, Juntendo University School of Medicine</s1><s2>Tokyo</s2><s3>JPN</s3><sZ>2 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>9 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Urabe, Takao" sort="Urabe, Takao" uniqKey="Urabe T" first="Takao" last="Urabe">Takao Urabe</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka</s1><s2>Urayasu, Chiba 279-0021</s2><s3>JPN</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>7 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Japon</country><wicri:noRegion>Urayasu, Chiba 279-0021</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Cardiovascular drugs and therapy</title><title level="j" type="abbreviated">Cardiovasc. drugs ther.</title><idno type="ISSN">0920-3206</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Cardiovascular drugs and therapy</title><title level="j" type="abbreviated">Cardiovasc. drugs ther.</title><idno type="ISSN">0920-3206</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antilipemic agent</term><term>Aorta</term><term>Atherosclerotic plaque</term><term>Echocardiography</term><term>Efficiency</term><term>Embolism</term><term>Encephalon</term><term>Hypocholesterolemic agent</term><term>Rosuvastatin</term><term>Stroke</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Efficacité</term><term>Accident cérébrovasculaire</term><term>Rosuvastatine</term><term>Traitement</term><term>Plaque d'athérosclérose</term><term>Aorte</term><term>Echocardiographie</term><term>Encéphale</term><term>Embolie</term><term>Hypolipémiant</term><term>Hypocholestérolémiant</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background Large atheromatous aortic plaques (AAPs) are associated with stroke recurrence. Rosuvastatin is a potent lipid-lowering agent and suppresses carotid and coronary artery atherosclerosis. It is unclear whether rosuvastatin has antiatherogenic effects against AAPs in stroke patients. We designed a clinical trial in stroke patients to analyze changes in AAPs after rosuvastatin treatment using repeated transesophageal echocardiography (TEE). Methods This trial is a prospective randomized open label study. Inclusion criteria were patients were ischemic stroke with hypercholesterolemia and AAPs >4 mm in thickness. The patients are randomly assigned to either a group treated with 5 mg/day rosuvastatin or a control group. Primary endpoint is the changes in volume and composition of AAPs after 6 months using transesophageal echocardiography (TEE). Biochemical findings are analyzed. By using repeated TEE and binary image analysis, we will be able to compare the dynamic changes in plaque composition of AAPs before and after therapy in the two groups. Conclusions The EPISTEME trial will provide information on the changes in plaque volume and composition achieved by improvement of lipid profiles with rosuvastatin therapy in stroke patients with aortic atherosclerosis. The results of the study may provide evidence for a therapeutic strategy for aortogenic brain embolism. This study is registered with UMIN-CTR (UMIN000010548).</div></front></TEI><affiliations><list><country><li>Japon</li></country><region><li>Région de Kantō</li></region><settlement><li>Tokyo</li></settlement></list><tree><country name="Japon"><noRegion><name sortKey="Ueno, Yuji" sort="Ueno, Yuji" uniqKey="Ueno Y" first="Yuji" last="Ueno">Yuji Ueno</name></noRegion><name sortKey="Daida, Hiroyuki" sort="Daida, Hiroyuki" uniqKey="Daida H" first="Hiroyuki" last="Daida">Hiroyuki Daida</name><name sortKey="Daimon, Masao" sort="Daimon, Masao" uniqKey="Daimon M" first="Masao" last="Daimon">Masao Daimon</name><name sortKey="Hattori, Nobutaka" sort="Hattori, Nobutaka" uniqKey="Hattori N" first="Nobutaka" last="Hattori">Nobutaka Hattori</name><name sortKey="Kuroki, Takuma" sort="Kuroki, Takuma" uniqKey="Kuroki T" first="Takuma" last="Kuroki">Takuma Kuroki</name><name sortKey="Miyamoto, Nobukazu" sort="Miyamoto, Nobukazu" uniqKey="Miyamoto N" first="Nobukazu" last="Miyamoto">Nobukazu Miyamoto</name><name sortKey="Miyauchi, Katsumi" sort="Miyauchi, Katsumi" uniqKey="Miyauchi K" first="Katsumi" last="Miyauchi">Katsumi Miyauchi</name><name sortKey="Shimada, Yoshiaki" sort="Shimada, Yoshiaki" uniqKey="Shimada Y" first="Yoshiaki" last="Shimada">Yoshiaki Shimada</name><name sortKey="Tanaka, Ryota" sort="Tanaka, Ryota" uniqKey="Tanaka R" first="Ryota" last="Tanaka">Ryota Tanaka</name><name sortKey="Tanaka, Yasutaka" sort="Tanaka, Yasutaka" uniqKey="Tanaka Y" first="Yasutaka" last="Tanaka">Yasutaka Tanaka</name><name sortKey="Urabe, Takao" sort="Urabe, Takao" uniqKey="Urabe T" first="Takao" last="Urabe">Takao Urabe</name><name sortKey="Watanabe, Masao" sort="Watanabe, Masao" uniqKey="Watanabe M" first="Masao" last="Watanabe">Masao Watanabe</name><name sortKey="Yamashiro, Kazuo" sort="Yamashiro, Kazuo" uniqKey="Yamashiro K" first="Kazuo" last="Yamashiro">Kazuo Yamashiro</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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