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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EArgatroban is a direct thrombin inhibitor that safely augments the benefit of tPA in animal stroke models; however, human data are limited. The Argatroban tPA Stroke Study [ARTSS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00268762\u0026amp;atom=%2Fspmdc%2F11%2F1%2F17.2.atom\u0022\u003ENCT00268762\u003C\/a\u003E] is a multicenter, Phase II, prospective, open-label, safety and activity study of argatroban and tPA in patients with ischemic stroke.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EIschemia Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe benefit of intravenous recombinant tissue plasminogen activator (tPA) in acute ischemic stroke is related to clot lysis and arterial recanalization. Argatroban is a direct thrombin inhibitor that safely augments the benefit of tPA in animal stroke models; however, human data are limited. The Argatroban tPA Stroke Study (ARTSS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00268762\u0026amp;atom=%2Fspmdc%2F11%2F1%2F17.2.atom\u0022\u003ENCT00268762\u003C\/a\u003E) is a multicenter, Phase II, prospective, open-label, safety and activity study of argatroban and tPA in patients with ischemic stroke. The final results of ARTSS were presented by Andrew D. Barreto, MD, and James C. Grotta, MD, University of Texas-Houston, Houston, Texas, on behalf of the ARTSS investigators.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe primary (safety) outcome for ARTSS was the incidence of significant (ie, symptomatic or PH-2) intracerebral hemorrhage (ICH). Secondary (signal of efficacy) outcomes included rates of recanalization, measured at 2 and 24 hours by transcranial Doppler (TCD) ultrasonography or CT-angiogram, and modified Rankin Scale score at discharge. There was also a preplanned historical control comparison with the control data (IV-rtPA alone) from the CLOTBUST study [Alexandrov AV et al. \u003Cem\u003ENEJM\u003C\/em\u003E 2004].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EEligibility included patients from 18 to 85 years of age who were admitted between 0 and 4.5 hours of stroke onset and met the criteria for intravenous tPA therapy. Subjects were also required to be within the NIH stroke scale (NIHSS) limits of 5\u201320 on the left hemisphere and 5\u201315 on the right hemisphere, have a proximal intracranial arterial occlusion that was measured by TCD or CT-angiogram, an INR \u22641.5, and no known hepatic disease. Subjects received full-dose IV-tPA (0.9 mg\/kg) plus argatroban, given as a 100-mcg\/kg bolus that was started during the tPA infusion and then as a 1-mcg\/kg infusion over 48 hours. Argatroban was titrated to a target partial thromboplastin time (PTT)=1.75 by the patient\u0027s baseline.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ESubjects (n=65) had a mean age of 63 years, and 45% were men. The median subject NIHSS score was 13. Ninety percent of patients had middle cerebral artery occlusions, and the majority of patients were enrolled using TCD (n=47). The median time from the symptom onset to tPA bolus was 128 minutes (interquartile range 94 to 170 minutes). There was a median time of 17 minutes of overlap for the tPA and argatroban.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ETarget PTT (+10%) was achieved. Significant ICH occurred in 4 subjects (6.2%); three of them were symptomatic hemorrhage (4.6%) and 2 were parenchymal hemorrhage type 2 (PH-2; 3.1%). One patient was symptomatic and had a PH-2. There were 185 adverse events; 28 were considered serious, 3 were likely related to the treatment, and none was considered definitely related to treatment. There were 7 deaths (10.8%) by discharge or Day 7.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EOf the 47 subjects who received TCD, 55% recanalized (complete recanalization in 30% and partial recanalization in 26%) at 2 hours. Five subjects (11%) recanalized before 2 hours but reoccluded at 2 hours. Of the 60 subjects with 24-hour data, 60% had complete recanalization and 18% had partial recanalization.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EWhen compared with the controls from the CLOTBUST study, significantly (p=0.03) more patients in ARTSS achieved complete recanalization at 2 hours (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). There was also a trend toward reduced reocclusion. No difference in symptomatic ICH was found. A randomized, controlled Phase IIb study is planned to confirm and extend these findings.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/1\/17.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Comparison to CLOTBUST Controls.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1816670410\u0022 data-figure-caption=\u0022Comparison to CLOTBUST Controls.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/1\/17.2\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/1\/17.2\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/11\/1\/17.2\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12230\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003EComparison to CLOTBUST Controls.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from A. Barreto, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/1\/17.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzn4kc\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn4kc\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}