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All the wide-scale trials that assessed the impacts of cilostazol versus clopidogrel in stroke management have been conducted in Asia and involved patients with minor stroke or TIA. Our trial is the first-ever study to evaluate cilostazol versus clopidogrel in acute LVO with moderate to severe ischemic stroke in North Africa.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Objectives<\/jats:title>\n            <jats:p>We assessed the efficacy and safety of cilostazol versus clopidogrel in first-ever LVO moderate and moderate to severe ischemic stroke patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>580 moderate and moderate-to-severe LVO ischemic stroke participants were randomly enrolled to receive loading and maintenance doses of cilostazol or clopidogrel.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>580 patients were included in the intention-to-treat analysis. 29 (10.0%) participants in the cilostazol arm and 43 (14.8%) participants in the clopidogrel arm experienced a new stroke (HR 0.37; 95% CI, 0.29\u20130.73; <jats:italic>P<\/jats:italic>-value\u2009=\u20090.03). Eight participants (2.8%) in the cilostazol arm and 17 patients (5.9%) in the clopidogrel arm had drug-related hemorrhagic complications (HR 0.29; 95% CI, 0.18\u20130.63; <jats:italic>P<\/jats:italic>-value\u2009=\u20090.008).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Patients who experienced acute LVO moderate and moderate-to-severe ischemic stroke and received loading and maintenance doses of cilostazol within the first 24\u00a0h after stroke onset had better clinical outcomes based on recurrent stroke rates and better safety outcomes regarding hemorrhagic transformation of brain infarction and drug-induced peripheral hemorrhagic side effects compared to those who received loading and maintenance doses of clopidogrel. There were no significant differences between the two groups regarding death due to vascular events and unfavorable mRS after three months of stroke onset.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Registration<\/jats:title>\n            <jats:p>Retrospectively registered on ClinicalTrials.gov, NCT06242145, 27\u201301-2024.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s10072-025-08107-9","type":"journal-article","created":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T23:45:05Z","timestamp":1744674305000},"page":"3973-3986","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Cilostazole versus clopidogrel in acute large-vessel moderate and moderate-to-severe ischemic stroke: a randomized controlled trial"],"prefix":"10.1007","volume":"46","author":[{"given":"Sherihan Rezk","family":"ahmed","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed Fouad elsayed","family":"Khalil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Ismaiel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarek Youssif","family":"Omar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hossam Mohamed","family":"Refat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed Ahmed Mohamed Kamal","family":"Ebied","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noha","family":"Abdelwahed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed Zaki Omar","family":"Akl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emad Labib Abdelhamid","family":"Mahmoud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salah Ibrahim","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asmaa Mohammed","family":"Hassan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Islam Fathallah Mohamed","family":"Kamel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir Ahmed Elsaeed","family":"Egila","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Abouelnaga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0337-349X","authenticated-orcid":false,"given":"Mohamed G.","family":"Zeinhom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,15]]},"reference":[{"issue":"1","key":"8107_CR1","doi-asserted-by":"publisher","first-page":"S4","DOI":"10.1093\/neuros\/nyz042","volume":"85","author":"RC Rennert","year":"2019","unstructured":"Rennert RC et al (2019) Epidemiology, Natural history, and clinical presentation of large vessel ischemic stroke. 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Zeinhom is the guarantor of the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Guarantor"}},{"value":"Our study had the approval of the ethical committee of Kafr El-sheikh University, and the ethical reference number is (KFSIRB200-145).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all subjects before the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Mohamed G. 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