Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient)
BACKGROUND AND PURPOSE—Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available. METHODS—We conducted a multicenter, open-label, randomized controlled trial in...
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| container_title | Stroke (1970) |
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| creator | Yoshimura, Shinichi Uchida, Kazutaka Daimon, Takashi Takashima, Ryuzo Kimura, Kazuhiro Morimoto, Takeshi Tanada, Shuichi Iida, Tomoko Kuroda, Junko Nose, Akinori Tatebayashi, Kotaro Shimizu, Fuminori Tsudaka, Shun Takeuchi, Masataka Hiyama, Nagayasu Oki, Yoshiharu Hagii, Joji Saito, Shin Matsumoto, Tsuyoshi Tanaka, Yasue Kuramoto, Yoji Mikami, Kazuyuki Shinoda, Narihide Shimo, Daisuke Soneda, Junichi Tokuda, Kou Matsuda, Kenichi Hiroto, Kakita Yamaura, Ikuya Okada, Takashi Hirano, Teruyuki Kuwayama, Naoya Teramukai, Satoshi |
| description | BACKGROUND AND PURPOSE—Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available.
METHODS—We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days.
RESULTS—A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups (P=0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53–1.3; P=0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups.
CONCLUSIONS—Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT02549846. |
| doi_str_mv | 10.1161/STROKEAHA.117.017623 |
| format | Article |
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METHODS—We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days.
RESULTS—A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups (P=0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53–1.3; P=0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups.
CONCLUSIONS—Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT02549846.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.117.017623</identifier><identifier>PMID: 29030478</identifier><language>eng</language><publisher>United States: American Heart Association, Inc</publisher><subject>Acute Disease ; Aged ; Aged, 80 and over ; Brain Ischemia - drug therapy ; Brain Ischemia - mortality ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage ; Japan ; Male ; Middle Aged ; Stroke - drug therapy ; Stroke - mortality ; Time Factors</subject><ispartof>Stroke (1970), 2017-11, Vol.48 (11), p.3057-3063</ispartof><rights>2017 American Heart Association, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3053-b3aa6a04169d7ee09aa71c7ffe8d11c8dd47d6839e4eeb09c823627ddd81cbad3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,781,785,3688,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29030478$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yoshimura, Shinichi</creatorcontrib><creatorcontrib>Uchida, Kazutaka</creatorcontrib><creatorcontrib>Daimon, Takashi</creatorcontrib><creatorcontrib>Takashima, Ryuzo</creatorcontrib><creatorcontrib>Kimura, Kazuhiro</creatorcontrib><creatorcontrib>Morimoto, Takeshi</creatorcontrib><creatorcontrib>Tanada, Shuichi</creatorcontrib><creatorcontrib>Iida, Tomoko</creatorcontrib><creatorcontrib>Kuroda, Junko</creatorcontrib><creatorcontrib>Nose, Akinori</creatorcontrib><creatorcontrib>Tatebayashi, Kotaro</creatorcontrib><creatorcontrib>Shimizu, Fuminori</creatorcontrib><creatorcontrib>Tsudaka, Shun</creatorcontrib><creatorcontrib>Takeuchi, Masataka</creatorcontrib><creatorcontrib>Hiyama, Nagayasu</creatorcontrib><creatorcontrib>Oki, Yoshiharu</creatorcontrib><creatorcontrib>Hagii, Joji</creatorcontrib><creatorcontrib>Saito, Shin</creatorcontrib><creatorcontrib>Matsumoto, Tsuyoshi</creatorcontrib><creatorcontrib>Tanaka, Yasue</creatorcontrib><creatorcontrib>Kuramoto, Yoji</creatorcontrib><creatorcontrib>Mikami, Kazuyuki</creatorcontrib><creatorcontrib>Shinoda, Narihide</creatorcontrib><creatorcontrib>Shimo, Daisuke</creatorcontrib><creatorcontrib>Soneda, Junichi</creatorcontrib><creatorcontrib>Tokuda, Kou</creatorcontrib><creatorcontrib>Matsuda, Kenichi</creatorcontrib><creatorcontrib>Hiroto, Kakita</creatorcontrib><creatorcontrib>Yamaura, Ikuya</creatorcontrib><creatorcontrib>Okada, Takashi</creatorcontrib><creatorcontrib>Hirano, Teruyuki</creatorcontrib><creatorcontrib>Kuwayama, Naoya</creatorcontrib><creatorcontrib>Teramukai, Satoshi</creatorcontrib><creatorcontrib>ASSORT Trial Investigator</creatorcontrib><title>Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient)</title><title>Stroke (1970)</title><addtitle>Stroke</addtitle><description>BACKGROUND AND PURPOSE—Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available.
METHODS—We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days.
RESULTS—A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups (P=0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53–1.3; P=0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups.
CONCLUSIONS—Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT02549846.</description><subject>Acute Disease</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Brain Ischemia - drug therapy</subject><subject>Brain Ischemia - mortality</subject><subject>Female</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</subject><subject>Japan</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Stroke - drug therapy</subject><subject>Stroke - mortality</subject><subject>Time Factors</subject><issn>0039-2499</issn><issn>1524-4628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UU1v1DAQtRCILoV_gJCP5ZDWjr1xzC1aFlq10la7AY6R154ooU68tR1Vy9_iD-Jqtz2hnmbezPs4PIQ-UnJOaUEvNvV6db2sLqsExTmhosjZKzSj85xnvMjL12hGCJNZzqU8Qe9C-E0IyVk5f4tOckkY4aKcob9rNRo39H_A4IUbo3fWprX2vbLYtXipvN3jn-DDFPBXsGqfvpuoYj_iugOvdnuc1tt0gDEG_KuPHa70FAFfBd3B0OtE9-4OvuBqs1mt66P3WWWGfuxD9Enqxseso20C_zV4Cvn8Hr1plQ3w4ThP0Y9vy3pxmd2svl8tqptMMzJn2ZYpVSjCaSGNACBSKUG1aFsoDaW6NIYLU5RMAgfYEqnLnBW5MMaUVG-VYafo7OC78-5-ghCboQ8arFUjuCk0VM4pp5xLnqj8QNXeheChbXa-H5TfN5Q0j3U1z3UlKJpDXUn26ZgwbQcwz6KnfhKhPBAenI2phDs7PYBvOlA2di97_wOAuqY2</recordid><startdate>201711</startdate><enddate>201711</enddate><creator>Yoshimura, Shinichi</creator><creator>Uchida, Kazutaka</creator><creator>Daimon, Takashi</creator><creator>Takashima, Ryuzo</creator><creator>Kimura, Kazuhiro</creator><creator>Morimoto, Takeshi</creator><creator>Tanada, Shuichi</creator><creator>Iida, Tomoko</creator><creator>Kuroda, Junko</creator><creator>Nose, Akinori</creator><creator>Tatebayashi, Kotaro</creator><creator>Shimizu, Fuminori</creator><creator>Tsudaka, Shun</creator><creator>Takeuchi, Masataka</creator><creator>Hiyama, Nagayasu</creator><creator>Oki, Yoshiharu</creator><creator>Hagii, Joji</creator><creator>Saito, Shin</creator><creator>Matsumoto, Tsuyoshi</creator><creator>Tanaka, Yasue</creator><creator>Kuramoto, Yoji</creator><creator>Mikami, Kazuyuki</creator><creator>Shinoda, Narihide</creator><creator>Shimo, Daisuke</creator><creator>Soneda, Junichi</creator><creator>Tokuda, Kou</creator><creator>Matsuda, Kenichi</creator><creator>Hiroto, Kakita</creator><creator>Yamaura, Ikuya</creator><creator>Okada, Takashi</creator><creator>Hirano, Teruyuki</creator><creator>Kuwayama, Naoya</creator><creator>Teramukai, Satoshi</creator><general>American Heart Association, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201711</creationdate><title>Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient)</title><author>Yoshimura, Shinichi ; Uchida, Kazutaka ; Daimon, Takashi ; Takashima, Ryuzo ; Kimura, Kazuhiro ; Morimoto, Takeshi ; Tanada, Shuichi ; Iida, Tomoko ; Kuroda, Junko ; Nose, Akinori ; Tatebayashi, Kotaro ; Shimizu, Fuminori ; Tsudaka, Shun ; Takeuchi, Masataka ; Hiyama, Nagayasu ; Oki, Yoshiharu ; Hagii, Joji ; Saito, Shin ; Matsumoto, Tsuyoshi ; Tanaka, Yasue ; Kuramoto, Yoji ; Mikami, Kazuyuki ; Shinoda, Narihide ; Shimo, Daisuke ; Soneda, Junichi ; Tokuda, Kou ; Matsuda, Kenichi ; Hiroto, Kakita ; Yamaura, Ikuya ; Okada, Takashi ; Hirano, Teruyuki ; Kuwayama, Naoya ; Teramukai, Satoshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3053-b3aa6a04169d7ee09aa71c7ffe8d11c8dd47d6839e4eeb09c823627ddd81cbad3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acute Disease</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Brain Ischemia - drug therapy</topic><topic>Brain Ischemia - mortality</topic><topic>Female</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage</topic><topic>Japan</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Stroke - drug therapy</topic><topic>Stroke - mortality</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yoshimura, Shinichi</creatorcontrib><creatorcontrib>Uchida, Kazutaka</creatorcontrib><creatorcontrib>Daimon, Takashi</creatorcontrib><creatorcontrib>Takashima, Ryuzo</creatorcontrib><creatorcontrib>Kimura, Kazuhiro</creatorcontrib><creatorcontrib>Morimoto, Takeshi</creatorcontrib><creatorcontrib>Tanada, Shuichi</creatorcontrib><creatorcontrib>Iida, Tomoko</creatorcontrib><creatorcontrib>Kuroda, Junko</creatorcontrib><creatorcontrib>Nose, Akinori</creatorcontrib><creatorcontrib>Tatebayashi, Kotaro</creatorcontrib><creatorcontrib>Shimizu, Fuminori</creatorcontrib><creatorcontrib>Tsudaka, Shun</creatorcontrib><creatorcontrib>Takeuchi, Masataka</creatorcontrib><creatorcontrib>Hiyama, Nagayasu</creatorcontrib><creatorcontrib>Oki, Yoshiharu</creatorcontrib><creatorcontrib>Hagii, Joji</creatorcontrib><creatorcontrib>Saito, Shin</creatorcontrib><creatorcontrib>Matsumoto, Tsuyoshi</creatorcontrib><creatorcontrib>Tanaka, Yasue</creatorcontrib><creatorcontrib>Kuramoto, Yoji</creatorcontrib><creatorcontrib>Mikami, Kazuyuki</creatorcontrib><creatorcontrib>Shinoda, Narihide</creatorcontrib><creatorcontrib>Shimo, Daisuke</creatorcontrib><creatorcontrib>Soneda, Junichi</creatorcontrib><creatorcontrib>Tokuda, Kou</creatorcontrib><creatorcontrib>Matsuda, Kenichi</creatorcontrib><creatorcontrib>Hiroto, Kakita</creatorcontrib><creatorcontrib>Yamaura, Ikuya</creatorcontrib><creatorcontrib>Okada, Takashi</creatorcontrib><creatorcontrib>Hirano, Teruyuki</creatorcontrib><creatorcontrib>Kuwayama, Naoya</creatorcontrib><creatorcontrib>Teramukai, Satoshi</creatorcontrib><creatorcontrib>ASSORT Trial Investigator</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yoshimura, Shinichi</au><au>Uchida, Kazutaka</au><au>Daimon, Takashi</au><au>Takashima, Ryuzo</au><au>Kimura, Kazuhiro</au><au>Morimoto, Takeshi</au><au>Tanada, Shuichi</au><au>Iida, Tomoko</au><au>Kuroda, Junko</au><au>Nose, Akinori</au><au>Tatebayashi, Kotaro</au><au>Shimizu, Fuminori</au><au>Tsudaka, Shun</au><au>Takeuchi, Masataka</au><au>Hiyama, Nagayasu</au><au>Oki, Yoshiharu</au><au>Hagii, Joji</au><au>Saito, Shin</au><au>Matsumoto, Tsuyoshi</au><au>Tanaka, Yasue</au><au>Kuramoto, Yoji</au><au>Mikami, Kazuyuki</au><au>Shinoda, Narihide</au><au>Shimo, Daisuke</au><au>Soneda, Junichi</au><au>Tokuda, Kou</au><au>Matsuda, Kenichi</au><au>Hiroto, Kakita</au><au>Yamaura, Ikuya</au><au>Okada, Takashi</au><au>Hirano, Teruyuki</au><au>Kuwayama, Naoya</au><au>Teramukai, Satoshi</au><aucorp>ASSORT Trial Investigator</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient)</atitle><jtitle>Stroke (1970)</jtitle><addtitle>Stroke</addtitle><date>2017-11</date><risdate>2017</risdate><volume>48</volume><issue>11</issue><spage>3057</spage><epage>3063</epage><pages>3057-3063</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><abstract>BACKGROUND AND PURPOSE—Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available.
METHODS—We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days.
RESULTS—A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups (P=0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53–1.3; P=0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups.
CONCLUSIONS—Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT02549846.</abstract><cop>United States</cop><pub>American Heart Association, Inc</pub><pmid>29030478</pmid><doi>10.1161/STROKEAHA.117.017623</doi><tpages>7</tpages></addata></record> |
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| ispartof | Stroke (1970), 2017-11, Vol.48 (11), p.3057-3063 |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Ovid Autoload; Alma/SFX Local Collection |
| subjects | Acute Disease Aged Aged, 80 and over Brain Ischemia - drug therapy Brain Ischemia - mortality Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage Japan Male Middle Aged Stroke - drug therapy Stroke - mortality Time Factors |
| title | Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient) |
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