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Patients with acute coronary syndromes (ACS) often do not achieve LDL\u2010C targets despite potent statin treatment, and have a particularly high risk of early recurrent events. Evolocumab, a proprotein convertase subtilisin\/kexin type (PCSK9)\u2010inhibitor resulting in rapid, marked LDL\u2010C reduction, has been studied in hypercholesterolemic subjects without CVD and stabilized patients with CVD; the feasibility, safety, and efficacy of this treatment initiated in the acute phase of ACS remain unknown. We report the design of evolocumab for early reduction of LDL\u2010cholesterol levels in patients with ACS (EVOPACS), a phase\u20103, multicenter, randomized, double\u2010blind, placebo\u2010controlled trial to assess the feasibility, safety, and LDL\u2010C\u2010lowering efficacy of evolocumab on top of atorvastatin 40\u2009mg in patients with ACS. The primary endpoint is percent change in LDL\u2010C from baseline to 8\u2009weeks. Secondary endpoints are adverse events and serious adverse events. Against a background of beneficial cardiovascular effects of statins beyond LDL\u2010C lowering and in view of preclinical evidence of similar effects of PCSK9 inhibition, the study will also address a variety of exploratory endpoints including the change in C\u2010reactive protein and other inflammatory biomarkers; platelet reactivity; and occurrence of contrast\u2010induced acute kidney injury and myocardial injury in patients undergoing cardiac catheterization. An intracoronary imaging sub\u2010study will investigate the change from baseline in the lipid core burden index in non\u2010culprit lesions, as assessed by serial near\u2010infrared spectroscopy. Recruitment began in January 2018 and enrollment of 308 patients is planned.<\/jats:p>","DOI":"10.1002\/clc.23112","type":"journal-article","created":{"date-parts":[[2018,11,13]],"date-time":"2018-11-13T02:45:51Z","timestamp":1542077151000},"page":"1513-1520","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Design of the randomized, placebo\u2010controlled evolocumab for early reduction of LDL\u2010cholesterol levels in patients with acute coronary syndromes (EVOPACS) trial"],"prefix":"10.1002","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5589-7762","authenticated-orcid":false,"given":"Konstantinos C.","family":"Koskinas","sequence":"first","affiliation":[{"name":"Department of Cardiology Bern University Hospital  Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Windecker","sequence":"additional","affiliation":[{"name":"Department of Cardiology Bern University Hospital  Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aliki","family":"Buhayer","sequence":"additional","affiliation":[{"name":"PRISM Scientific S\u00e0rl  Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baris","family":"Gencer","sequence":"additional","affiliation":[{"name":"Department of Cardiology Geneva University Hospital  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Pedrazzini","sequence":"additional","affiliation":[{"name":"Cardiocentro  Lugano Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Mueller","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiovascular Research Institute Basel University Hospital Basel  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Cook","sequence":"additional","affiliation":[{"name":"Department of Cardiology Fribourg Hospital and University  Fribourg Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Muller","sequence":"additional","affiliation":[{"name":"Service of Cardiology Lausanne University Hospital  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian M.","family":"Matter","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Heart Center University Hospital Zurich  Zurich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenz","family":"R\u00e4ber","sequence":"additional","affiliation":[{"name":"Department of Cardiology Bern University Hospital  Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dik","family":"Heg","sequence":"additional","affiliation":[{"name":"CTU Bern University of Bern  Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois","family":"Mach","sequence":"additional","affiliation":[{"name":"Department of Cardiology Geneva University Hospital  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the EVOPACS Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,26]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv320"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehx566"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2005.03.077"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.13.1711"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.2444"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw272"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1615664"},{"key":"e_1_2_6_9_1","unstructured":"SchwartzGG SzarekM BhattDL et al. 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