259 0

Full metadata record

DC FieldValueLanguage
dc.contributor.author신진호-
dc.date.accessioned2017-05-29T05:29:02Z-
dc.date.available2017-05-29T05:29:02Z-
dc.date.issued2015-09-
dc.identifier.citationCURRENT MEDICAL RESEARCH AND OPINION, v. 31, NO 3, Page. 449-457en_US
dc.identifier.issn0300-7995-
dc.identifier.issn1473-4877-
dc.identifier.urihttp://www.tandfonline.com/doi/abs/10.1185/03007995.2015.1006726-
dc.identifier.urihttp://hdl.handle.net/20.500.11754/27508-
dc.description.abstractObjective: Clopidogrel is indicated for the treatment and prevention of peripheral vascular, cerebrovascular, and coronary artery diseases. This clinical trial was designed to demonstrate that clopidogrel napadisilate (CN) is not inferior to clopidogrel bisulfate (CB) with respect to its effectiveness in inhibiting platelet aggregation. Methods: This 4 week multi-center, prospective, open-label, randomized trial was conducted at five clinical centers in South Korea. Patients were randomized into the 75 mg CN group or the 75 mg CB group. Platelet aggregation was assessed by the VerifyNow assay. The primary outcome was the difference of the percentage P2Y(12) inhibition and the secondary outcome was the baseline and change in P2Y(12) reaction units (PRU). Results: There was no significant difference in the percentage P2Y(12) inhibition (CN vs. CB, 34.92 +/- 21.33% vs. 30.43 +/- 17.90%, p = 0.203). The mean difference of the percentage P2Y(12) inhibition between groups was 4.49%, their two-sided 95% confidence interval was -2.45% to 11.44%, and the lower bound (-2.45%) was greater than the acceptable non-inferiority margin of -9.0%. The baseline PRU was 96.67 +/- 76.76 in the CN group and 216.95 +/- 68.86 in the CB group (p = 0.121), and the change in the PRU was -3.32 +/- 51.71 in the CN group and 10.52 +/- 43.31 in the CB group (p = 0.106). Four subjects experienced AEs (6.3%, 5 events) in the CN group and 7 subjects (11.11%, 13 events) in the CB group without statistical significance (p = 0.364). With respect to serious adverse events, 2 events were reported in 2 subjects, 1 in each group. Conclusion: Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability, and there were no clinically significant adverse events.en_US
dc.description.sponsorshipThis research was financially sponsored by Hanmi Pharmaceutical Co. Ltd, Seoul, South Korea. The sponsor supported only laboratory testing, study medication, and clinical research coordinator expenses. The study was an investigator initiated trial, and the sponsor had no involvement in the study design, collection, analysis, and interpretation of data, or writing the manuscript. Hanmi Pharmaceutical also had no input into the decision to submit this article for publication. The authors had full access to all the data in the study, and the corresponding author had the final responsibility to submit the manuscript for publication.en_US
dc.language.isoenen_US
dc.publisherINFORMA HEALTHCAREen_US
dc.subjectClopidogrel bisulfateen_US
dc.subjectClopidogrel napadisilateen_US
dc.subjectEfficacyen_US
dc.subjectP2Y(12)en_US
dc.titleAssessment of the efficacy and tolerability of clopidogrel napadisilate in Korean patients with coronary stenting: a multicenter, prospective, open-label, randomized trialen_US
dc.typeArticleen_US
dc.relation.no3-
dc.relation.volume31-
dc.identifier.doi10.1185/03007995.2015.1006726-
dc.relation.page449-457-
dc.relation.journalCURRENT MEDICAL RESEARCH AND OPINION-
dc.contributor.googleauthorKim, Sang Hoon-
dc.contributor.googleauthorSung, Jung-Hoon-
dc.contributor.googleauthorShin, JInho-
dc.contributor.googleauthorLee, Hyun Jong-
dc.contributor.googleauthorLee, Hyun Sang-
dc.contributor.googleauthorCho, Deok Kyu-
dc.contributor.googleauthorLim, Sang Wook-
dc.relation.code2015000730-
dc.sector.campusS-
dc.sector.daehakCOLLEGE OF MEDICINE[S]-
dc.sector.departmentDEPARTMENT OF MEDICINE-
dc.identifier.pidjhs2003-
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
Files in This Item:
There are no files associated with this item.
Export
RIS (EndNote)
XLS (Excel)
XML


qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

BROWSE