{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T00:59:45Z","timestamp":1767142785614,"version":"build-2238731810"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2021,4,4]],"date-time":"2021-04-04T00:00:00Z","timestamp":1617494400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,4,4]],"date-time":"2021-04-04T00:00:00Z","timestamp":1617494400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cardiovasc Interv and Ther"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75\u00a0mg as part of dual antiplatelet therapy (DAPT) for the prevention of recurrent ischemia and stent thrombosis in acute coronary syndrome (ACS). This modified dosage regimen has been established in studies conducted in Japan; however, the efficacy and safety of switching from clopidogrel to prasugrel DAPT among Taiwanese patients remain to be explored. In this phase IV, multicenter, single-arm, open-label study, we evaluated the 4-week pharmacodynamic response, and the 48-week safety outcomes of prasugrel 3.75\u00a0mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-na\u00efve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2\u00a0weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75\u00a0mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean\u2009\u2212\u200918.2\u2009\u00b1\u200948.1; 95% confidence interval\u2009\u2212\u200924.9 to\u2009\u2212\u200911.5,\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU\u2009&gt;\u2009208) dropped from 23.5 to 10% (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age\u2009\u2265\u200965\u00a0years, and body mass index\u2009\u2265\u200925 best predicted HPR at Week 4. Throughout the 48-week treatment with prasugrel, the incidences of MACE (1.0%) and TIMI major bleeding (2.0%) were rather low, accompanying an acceptable safety profile of TIMI minor (6.4%) and non-major, non-minor clinically relevant bleeding (3.0%). Overall, switching to the maintenance dose of prasugrel (3.75\u00a0mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.\n                  <\/jats:p>","DOI":"10.1007\/s12928-021-00771-w","type":"journal-article","created":{"date-parts":[[2021,4,4]],"date-time":"2021-04-04T07:02:16Z","timestamp":1617519736000},"page":"269-278","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy"],"prefix":"10.1007","volume":"37","clinical-trial-number":[{"clinical-trial-number":"nct03672097","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Ping-Yen","family":"Liu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng-Huang","family":"Su","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng-Yu","family":"Kuo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen-Lieng","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi-Chih","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei-Shiang","family":"Lin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pao-Hsien","family":"Chu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tse-Min","family":"Lu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ping-Han","family":"Lo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng-Han","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei-Ren","family":"Lan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chien-Lung","family":"Huang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuji","family":"Tsukiyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei-Chen","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li-Chung","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia","family":"Rafael","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Nikolajsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei-Hsian","family":"Yin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,4,4]]},"reference":[{"key":"771_CR1","doi-asserted-by":"publisher","first-page":"S3","DOI":"10.1016\/j.ahj.2008.06.003","volume":"156","author":"DJ Angiolillo","year":"2008","unstructured":"Angiolillo DJ, Guzman LA, Bass TA. 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Virginia Rafael and Christian Nikolajsen are Linical employees and participated in a project sponsored by Daiichi Sankyo. Wen-Lieng Lee was a chair of a meeting sponsored by Daiichi Sankyo.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The Switch Study protocol was approved by the institutional ethics committees of each study site prior to study initiation. This study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice, the local laws and regulations of Taiwan, and the Declaration of Helsinki. The study was sponsored by Daiichi Sankyo Co., Ltd., and registered on\n                      \n                      (Registration Number: NCT03672097).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent for trial participation was obtained from all study subjects before trial screening. A separate informed consent for <i>CYP2C19<\/i> genotyping was provided at trial screening, and only those who provided the corresponding written informed consent were subjected to such a test.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}