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To some extent, this may be attributable to incomplete microvascular reperfusion, which can possibly be improved by antiplatelet agents and heparin. It is unknown whether periprocedural antithrombotic medication in patients treated with EVT improves functional outcome. The aim of this study is to assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin (UFH), alone, or in combination, given to patients with an ischemic stroke caused by an intracranial large vessel occlusion in the anterior circulation during EVT.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>MR CLEAN-MED is a multicenter phase III trial with a prospective, 2\u2009\u00d7\u20093 factorial randomized, open label, blinded end-point (PROBE) design, which aims to enroll 1500 patients. The trial is designed to evaluate the effect of intravenous ASA (300\u2009mg), UFH (low or moderate dose), both or neither as adjunctive therapy to EVT. We enroll adult patients with a clinical diagnosis of stroke (NIHSS \u2265\u20092) and with a confirmed intracranial large vessel occlusion in the anterior circulation on CTA or MRA, when EVT within 6\u2009h from symptom onset is indicated and possible. The primary outcome is the score on the modified Rankin Scale (mRS) at 90\u2009days. Treatment effect on the mRS will be estimated with ordinal logistic regression analysis, with adjustment for main prognostic variables. Secondary outcomes include stroke severity measured with the NIHSS at 24\u2009h and at 5\u20137\u2009days, follow-up infarct volume, symptomatic intracranial hemorrhage (sICH), and mortality.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>Clinical equipoise exists whether antithrombotic medication should be administered during EVT for a large vessel occlusion, as ASA and\/or UFH may improve functional outcome, but might also lead to an increased risk of sICH. When one or both of the study treatments show the anticipated effect on outcome, we will be able to improve outcome of patients treated with EVT by 5%. This amounts to more than 50 patients annually in the Netherlands, more than 1800 in Europe, and more than 1300 in the USA.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ISRCT, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.isrctn.com\/ISRCTN76741621\">ISRCTN76741621<\/jats:ext-link>. Dec 6, 2017.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-020-04514-9","type":"journal-article","created":{"date-parts":[[2020,7,14]],"date-time":"2020-07-14T13:29:27Z","timestamp":1594733367000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design"],"prefix":"10.1186","volume":"21","author":[{"given":"Vicky","family":"Chalos","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"A. van de Graaf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8320-8303","authenticated-orcid":false,"given":"Bob","family":"Roozenbeek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriaan","family":"C. G. 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Written informed consent (deferred) for trial participation and their anonymized information to be published will be obtained from patient(s) or their legal representatives.EUDRACT: NL61364.078.17ISRCTN: ISRCTN76741621","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"WvZ: reports that Maastricht University Medical Center received compensation from Stryker\u00ae and Cerenovus\u00ae for consultations by WvZ;YR: reports that he is a shareholder of NicolabCM: reports that Amsterdam UMC received research grants form CVON\/Dutch Heart Foundation, European Commission, TWIN Foundation and Stryker\u00ae; he is a shareholder of Nico-Lab.AvdL: reports that Erasmus MC received research grants from Dutch Heart Foundation, Dutch Brain Foundation, AngioCare BV, Covidien\/EV3\u00ae, MEDAC Gmbh\/LAMEPRO, Penumbra Inc., Stryker, and Top Medical\/Concentric, The Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health, Stryker European Operations BV, Thrombolytic Science, LLC, and Cerenovus; he also reports that Erasmus MC received compensation from Stryker for activities of AvdL as a consultant outside the submitted work.DD: reports that Erasmus MC received research grants from Dutch Heart Foundation, Dutch Brain Foundation, AngioCare BV, Covidien\/EV3\u00ae, MEDAC Gmbh\/LAMEPRO, Penumbra Inc., Stryker, and Top Medical\/Concentric, The Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health, Stryker European Operations BV, Thrombolytic Science, LLC, and Cerenovus.All other authors: declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"644"}}