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Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy
The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg 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 establi...
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| Published in: | Cardiovascular intervention and therapeutics 2022-04, Vol.37 (2), p.269-278 |
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| creator | Liu, Ping-Yen Su, Cheng-Huang Kuo, Feng-Yu Lee, Wen-Lieng Wang, Yi-Chih Lin, Wei-Shiang Chu, Pao-Hsien Lu, Tse-Min Lo, Ping-Han Lee, Cheng-Han Lan, Wei-Ren Huang, Chien-Lung Tsukiyama, Shuji Yang, Wei-Chen Cheng, Li-Chung Rafael, Virginia Nikolajsen, Christian Yin, Wei-Hsian |
| description | The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg 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 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5,
p
208) dropped from 23.5 to 10% (
p
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| doi_str_mv | 10.1007/s12928-021-00771-w |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8926957</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2508893649</sourcerecordid><originalsourceid>FETCH-LOGICAL-c536t-5c55d60de95c9c7eede92f8dbb614a445e1f075ed51b8072e9284e1d30caf1f43</originalsourceid><addsrcrecordid>eNp9Uc1uFSEUnhgb27R9AReGpZtRfoYZcGFimlpNmthFuyZc5nBLMxdGmOnNPI8v6mmnrbqRkHDg--HAV1VvGf3AKO0-FsY1VzXlrMZtx-r9q-qIqVbVDdfd6-daUHpYnZZyR3FwrXUj3lSHQigmOt4dVb-usi3zNsNAyj5M7jbELfE57Ygb0hj69AhZP0EmI2Q3TzZCmgtxKado80JCROwe4hRSJD5lYpEEf_CyxB79AInk2oY96guQ0U4BNeUTsRGnHZYSCkmeFOthWvCoJ-B9cNYtJ9WBt0OB06f1uLr5en599q2-_HHx_ezLZe2kaKdaOin7lvagpdOuA8CKe9VvNi1rbNNIYJ52EnrJNop2HFHVAOsFddYz34jj6vPqO86bHfQO-8t2MGMOO3yISTaYf5EYbs023Ruleatlhwbvnwxy-jlDmcwuFAfDsP6Z4ZIqpUXbaKTylepyKiWDf7mGUfMQsFkDNhiweQzY7FH07u8GXyTPcSJBrISCUNxCNndpzvi75X-2vwEbI7iu</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2508893649</pqid></control><display><type>article</type><title>Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy</title><source>Springer Nature</source><creator>Liu, Ping-Yen ; Su, Cheng-Huang ; Kuo, Feng-Yu ; Lee, Wen-Lieng ; Wang, Yi-Chih ; Lin, Wei-Shiang ; Chu, Pao-Hsien ; Lu, Tse-Min ; Lo, Ping-Han ; Lee, Cheng-Han ; Lan, Wei-Ren ; Huang, Chien-Lung ; Tsukiyama, Shuji ; Yang, Wei-Chen ; Cheng, Li-Chung ; Rafael, Virginia ; Nikolajsen, Christian ; Yin, Wei-Hsian</creator><creatorcontrib>Liu, Ping-Yen ; Su, Cheng-Huang ; Kuo, Feng-Yu ; Lee, Wen-Lieng ; Wang, Yi-Chih ; Lin, Wei-Shiang ; Chu, Pao-Hsien ; Lu, Tse-Min ; Lo, Ping-Han ; Lee, Cheng-Han ; Lan, Wei-Ren ; Huang, Chien-Lung ; Tsukiyama, Shuji ; Yang, Wei-Chen ; Cheng, Li-Chung ; Rafael, Virginia ; Nikolajsen, Christian ; Yin, Wei-Hsian</creatorcontrib><description>The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg 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 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5,
p
< 0.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU > 208) dropped from 23.5 to 10% (
p
< 0.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age ≥ 65 years, and body mass index ≥ 25 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 mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.</description><identifier>ISSN: 1868-4300</identifier><identifier>ISSN: 1868-4297</identifier><identifier>EISSN: 1868-4297</identifier><identifier>DOI: 10.1007/s12928-021-00771-w</identifier><identifier>PMID: 33813727</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Acute Coronary Syndrome - drug therapy ; Acute Coronary Syndrome - surgery ; Aged ; Cardiology ; Clopidogrel - adverse effects ; Female ; Humans ; Interventional Radiology ; Male ; Medicine ; Medicine & Public Health ; NCT ; NCT03672097 ; Original ; Original Article ; Percutaneous Coronary Intervention - adverse effects ; Platelet Aggregation Inhibitors - adverse effects ; Prasugrel Hydrochloride - adverse effects ; Ticlopidine - therapeutic use ; Treatment Outcome</subject><ispartof>Cardiovascular intervention and therapeutics, 2022-04, Vol.37 (2), p.269-278</ispartof><rights>The Author(s) 2021</rights><rights>2021. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c536t-5c55d60de95c9c7eede92f8dbb614a445e1f075ed51b8072e9284e1d30caf1f43</citedby><cites>FETCH-LOGICAL-c536t-5c55d60de95c9c7eede92f8dbb614a445e1f075ed51b8072e9284e1d30caf1f43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33813727$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Liu, Ping-Yen</creatorcontrib><creatorcontrib>Su, Cheng-Huang</creatorcontrib><creatorcontrib>Kuo, Feng-Yu</creatorcontrib><creatorcontrib>Lee, Wen-Lieng</creatorcontrib><creatorcontrib>Wang, Yi-Chih</creatorcontrib><creatorcontrib>Lin, Wei-Shiang</creatorcontrib><creatorcontrib>Chu, Pao-Hsien</creatorcontrib><creatorcontrib>Lu, Tse-Min</creatorcontrib><creatorcontrib>Lo, Ping-Han</creatorcontrib><creatorcontrib>Lee, Cheng-Han</creatorcontrib><creatorcontrib>Lan, Wei-Ren</creatorcontrib><creatorcontrib>Huang, Chien-Lung</creatorcontrib><creatorcontrib>Tsukiyama, Shuji</creatorcontrib><creatorcontrib>Yang, Wei-Chen</creatorcontrib><creatorcontrib>Cheng, Li-Chung</creatorcontrib><creatorcontrib>Rafael, Virginia</creatorcontrib><creatorcontrib>Nikolajsen, Christian</creatorcontrib><creatorcontrib>Yin, Wei-Hsian</creatorcontrib><title>Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy</title><title>Cardiovascular intervention and therapeutics</title><addtitle>Cardiovasc Interv and Ther</addtitle><addtitle>Cardiovasc Interv Ther</addtitle><description>The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg 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 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5,
p
< 0.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU > 208) dropped from 23.5 to 10% (
p
< 0.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age ≥ 65 years, and body mass index ≥ 25 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 mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.</description><subject>Acute Coronary Syndrome - drug therapy</subject><subject>Acute Coronary Syndrome - surgery</subject><subject>Aged</subject><subject>Cardiology</subject><subject>Clopidogrel - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Interventional Radiology</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>NCT</subject><subject>NCT03672097</subject><subject>Original</subject><subject>Original Article</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Platelet Aggregation Inhibitors - adverse effects</subject><subject>Prasugrel Hydrochloride - adverse effects</subject><subject>Ticlopidine - therapeutic use</subject><subject>Treatment Outcome</subject><issn>1868-4300</issn><issn>1868-4297</issn><issn>1868-4297</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9Uc1uFSEUnhgb27R9AReGpZtRfoYZcGFimlpNmthFuyZc5nBLMxdGmOnNPI8v6mmnrbqRkHDg--HAV1VvGf3AKO0-FsY1VzXlrMZtx-r9q-qIqVbVDdfd6-daUHpYnZZyR3FwrXUj3lSHQigmOt4dVb-usi3zNsNAyj5M7jbELfE57Ygb0hj69AhZP0EmI2Q3TzZCmgtxKado80JCROwe4hRSJD5lYpEEf_CyxB79AInk2oY96guQ0U4BNeUTsRGnHZYSCkmeFOthWvCoJ-B9cNYtJ9WBt0OB06f1uLr5en599q2-_HHx_ezLZe2kaKdaOin7lvagpdOuA8CKe9VvNi1rbNNIYJ52EnrJNop2HFHVAOsFddYz34jj6vPqO86bHfQO-8t2MGMOO3yISTaYf5EYbs023Ruleatlhwbvnwxy-jlDmcwuFAfDsP6Z4ZIqpUXbaKTylepyKiWDf7mGUfMQsFkDNhiweQzY7FH07u8GXyTPcSJBrISCUNxCNndpzvi75X-2vwEbI7iu</recordid><startdate>20220401</startdate><enddate>20220401</enddate><creator>Liu, Ping-Yen</creator><creator>Su, Cheng-Huang</creator><creator>Kuo, Feng-Yu</creator><creator>Lee, Wen-Lieng</creator><creator>Wang, Yi-Chih</creator><creator>Lin, Wei-Shiang</creator><creator>Chu, Pao-Hsien</creator><creator>Lu, Tse-Min</creator><creator>Lo, Ping-Han</creator><creator>Lee, Cheng-Han</creator><creator>Lan, Wei-Ren</creator><creator>Huang, Chien-Lung</creator><creator>Tsukiyama, Shuji</creator><creator>Yang, Wei-Chen</creator><creator>Cheng, Li-Chung</creator><creator>Rafael, Virginia</creator><creator>Nikolajsen, Christian</creator><creator>Yin, Wei-Hsian</creator><general>Springer Singapore</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20220401</creationdate><title>Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy</title><author>Liu, Ping-Yen ; Su, Cheng-Huang ; Kuo, Feng-Yu ; Lee, Wen-Lieng ; Wang, Yi-Chih ; Lin, Wei-Shiang ; Chu, Pao-Hsien ; Lu, Tse-Min ; Lo, Ping-Han ; Lee, Cheng-Han ; Lan, Wei-Ren ; Huang, Chien-Lung ; Tsukiyama, Shuji ; Yang, Wei-Chen ; Cheng, Li-Chung ; Rafael, Virginia ; Nikolajsen, Christian ; Yin, Wei-Hsian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c536t-5c55d60de95c9c7eede92f8dbb614a445e1f075ed51b8072e9284e1d30caf1f43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Acute Coronary Syndrome - drug therapy</topic><topic>Acute Coronary Syndrome - surgery</topic><topic>Aged</topic><topic>Cardiology</topic><topic>Clopidogrel - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Interventional Radiology</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>NCT</topic><topic>NCT03672097</topic><topic>Original</topic><topic>Original Article</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Platelet Aggregation Inhibitors - adverse effects</topic><topic>Prasugrel Hydrochloride - adverse effects</topic><topic>Ticlopidine - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Liu, Ping-Yen</creatorcontrib><creatorcontrib>Su, Cheng-Huang</creatorcontrib><creatorcontrib>Kuo, Feng-Yu</creatorcontrib><creatorcontrib>Lee, Wen-Lieng</creatorcontrib><creatorcontrib>Wang, Yi-Chih</creatorcontrib><creatorcontrib>Lin, Wei-Shiang</creatorcontrib><creatorcontrib>Chu, Pao-Hsien</creatorcontrib><creatorcontrib>Lu, Tse-Min</creatorcontrib><creatorcontrib>Lo, Ping-Han</creatorcontrib><creatorcontrib>Lee, Cheng-Han</creatorcontrib><creatorcontrib>Lan, Wei-Ren</creatorcontrib><creatorcontrib>Huang, Chien-Lung</creatorcontrib><creatorcontrib>Tsukiyama, Shuji</creatorcontrib><creatorcontrib>Yang, Wei-Chen</creatorcontrib><creatorcontrib>Cheng, Li-Chung</creatorcontrib><creatorcontrib>Rafael, Virginia</creatorcontrib><creatorcontrib>Nikolajsen, Christian</creatorcontrib><creatorcontrib>Yin, Wei-Hsian</creatorcontrib><collection>SpringerOpen</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cardiovascular intervention and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Liu, Ping-Yen</au><au>Su, Cheng-Huang</au><au>Kuo, Feng-Yu</au><au>Lee, Wen-Lieng</au><au>Wang, Yi-Chih</au><au>Lin, Wei-Shiang</au><au>Chu, Pao-Hsien</au><au>Lu, Tse-Min</au><au>Lo, Ping-Han</au><au>Lee, Cheng-Han</au><au>Lan, Wei-Ren</au><au>Huang, Chien-Lung</au><au>Tsukiyama, Shuji</au><au>Yang, Wei-Chen</au><au>Cheng, Li-Chung</au><au>Rafael, Virginia</au><au>Nikolajsen, Christian</au><au>Yin, Wei-Hsian</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy</atitle><jtitle>Cardiovascular intervention and therapeutics</jtitle><stitle>Cardiovasc Interv and Ther</stitle><addtitle>Cardiovasc Interv Ther</addtitle><date>2022-04-01</date><risdate>2022</risdate><volume>37</volume><issue>2</issue><spage>269</spage><epage>278</epage><pages>269-278</pages><issn>1868-4300</issn><issn>1868-4297</issn><eissn>1868-4297</eissn><abstract>The recommended maintenance dose of prasugrel for East Asian populations (i.e., Japanese and Taiwanese) is 3.75 mg 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 mg after a switch from clopidogrel in Taiwanese ACS patients. A total of 203 prasugrel-naïve ACS patients (over 90% male) who had received post-PCI clopidogrel DAPT for at least 2 weeks were enrolled from ten medical centers in Taiwan and subsequently switched to prasugrel 3.75 mg DAPT. Four weeks after the switch, P2Y12 reaction unit (PRU) values were significantly decreased in the total cohort (mean − 18.2 ± 48.1; 95% confidence interval − 24.9 to − 11.5,
p
< 0.001), and there was an overall consistent antiplatelet response in the treated subjects. The proportion of patients with high on-treatment platelet reactivity (HPR; PRU > 208) dropped from 23.5 to 10% (
p
< 0.001). Female sex was associated with a greater PRU reduction with prasugrel, whereas HPR at baseline, age ≥ 65 years, and body mass index ≥ 25 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 mg) was observed to be effective and well tolerated among post-PCI ACS patients in Taiwan. Clinical Trial Registration Number: NCT03672097.</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><pmid>33813727</pmid><doi>10.1007/s12928-021-00771-w</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Cardiovascular intervention and therapeutics, 2022-04, Vol.37 (2), p.269-278 |
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| source | Springer Nature |
| subjects | Acute Coronary Syndrome - drug therapy Acute Coronary Syndrome - surgery Aged Cardiology Clopidogrel - adverse effects Female Humans Interventional Radiology Male Medicine Medicine & Public Health NCT NCT03672097 Original Original Article Percutaneous Coronary Intervention - adverse effects Platelet Aggregation Inhibitors - adverse effects Prasugrel Hydrochloride - adverse effects Ticlopidine - therapeutic use Treatment Outcome |
| title | Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy |
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