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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.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\u003EA single dose of inclacumab, a fully human recombinant monoclonal antibody directed against P-selectin, appears to reduce myocardial damage in patients undergoing percutaneous coronary intervention (PCI) as measured by biomarker concentration. Results from a randomized Phase 2 trial showed a reduction in levels of troponin I at 16 and 24 hours post PCI with a single dose of incalcumab 20 mg\/kg when administered prior to PCI. The effect of a single dose of inclacumab on myocardial damage was examined in the Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention [SELECT-ACS; Tardif JC et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2013].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Myocardial Infarction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMyocardial Infarction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA single dose of inclacumab, a fully human recombinant monoclonal antibody directed against P-selectin, appears to reduce myocardial damage in patients undergoing percutaneous coronary intervention (PCI) as measured by biomarker concentration. Results from a randomized Phase 2 trial showed a reduction in levels of troponin I at 16 and 24 hours post PCI with a single dose of incalcumab 20 mg\/kg when administered prior to PCI.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EP-selectin is an adhesion molecule expressed on activated endothelial cells. It modulates interactions between white blood cells and platelets, acting as a crossroads of inflammation and thrombosis. It has been hypothesized that inhibition of P-selectin may reduce myocardial damage in the setting of PCI through both anti-inflammatory and anti-thrombotic effects.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe effect of a single dose of inclacumab on myocardial damage was examined in the Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (NSTEMI) Undergoing Percutaneous Coronary Intervention [SELECT-ACS; Tardif JC et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2013]. Results were presented by Jean-Claude Tardif, MD, Montreal Heart Institute, Montreal, Quebec, Canada.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ESELECT-ACS randomized NSTEMI patients to a single infusion of 5 or 20 mg\/kg of inclacumab or matching placebo, administered 1 to 24 hours prior to PCI. To be eligible, patients had to be scheduled for catheterization and intended to undergo PCI. The primary endpoint was the change in troponin I (Tn-I) at 16 and 24 hours post PCI.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOf the 544 patients randomized, the efficacy analysis included 322 patients who received study medication, underwent PCI and had biomarkers assayed at all timepoints.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe duration of PCI and rates of drug-eluting and bare-metal stent deployment were similar between the 3 arms, as were use of concomitant medications.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe mean percent change in Tn-I was \u221222.4% at 16 hours (p=0.07) and \u221224.4% (p=0.05) for patients receiving inclacumab 20 mg\/kg relative to those receiving placebo. Peak Tn-I was numerically reduced by 23.8% with this dose (p=0.05). There was no significant difference in Tn-I concentration observed with inclacumab 5 mg\/kg at either timepoint.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe percent change in Tn-I at 24 hours with inclacumab 20 mg\/kg versus placebo was similar in patients with or without diabetes (\u221233.2% and vs \u221231.6% respectively; p=0.03 in patients without diabetes; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/13132\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/13132\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13132\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EChange in Troponin I at 24 Hours\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-14\u0022\u003EThe change in creatine kinase-myocardial band (CK-MB) was similar to the findings for troponin with a borderline significant result in favor of high-dose inclacumab (\u221217.4% vs placebo; p=0.06). The incidence of CK-MB increases more than 3 times the upper limit of normal was 18.3% in the placebo group and 8.9% in the inclacumab 20 mg\/kg group (p=0.05).\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003ESafety data were collected at 120 days, at which time there was no increase in the rates of infection or bleeding with inclacumab. Of note, there were higher numbers of deaths (6 vs 0) and nonfatal MI (11 vs 2) in patients randomized to inclacumab versus placebo but the study was not adequately powered to detect differences in clinical endpoints.\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003EWhile these findings show a favorable pattern in biomarker concentration with high-dose inclacumab in the setting of PCI for NSTEMI, the clinical relevance of these findings is not clear from this Phase 2 study. Further clinical investigation is required to determine the clinical impact of inclacumab administration in patients presenting with MI.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\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\/13\/2\/19.2.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_openurl.js?nzo172\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_tables.js?nzo172\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}