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Rationale and Design for a Randomized Comparison of Efficacy and Safety between Aspirin and Clopidogrel in Atrial Fibrillation Patients with Low Stroke Risk: CESAC-AF trial

DC FieldValueLanguage
dc.contributor.author홍명기-
dc.date.accessioned2018-07-20T08:11:42Z-
dc.date.available2018-07-20T08:11:42Z-
dc.date.issued2017-
dc.identifier.issn1551-7144-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/160945-
dc.description.abstractBACKGROUND: Atrial fibrillation (AF) increases the risk of thromboembolic stroke. An oral anticoagulant should be administrated to prevent stroke in patients with moderate stroke risk (ie, CHA2DS2-VASc score>2). If the stroke risk is low (i.e. the score=1), however, antiplatelet agent such as aspirin is widely used. Aspirin can cause peptic ulcer disease (PUD) while its alternative, clopidogrel, theoretically does not. OBJECTIVE: To elucidate the efficacy and safety between aspirin and clopidogrel, a multicenter randomized controlled trial was designed in AF patients with low stroke risk. METHODS: According to sample size estimation based on previous literature, a total of 1560 AF patients with low stroke risk will be randomly assigned into 4 different groups dependent upon initial esophagogastroduodenoscopy (EGD) results: two mono-antiplatelet treatment groups with either aspirin 100mg or clopidogrel 75mg for 1year; two antiplatelet agent and proton pump inhibitor (PPI) combination groups. Follow-up EGD will be performed at 1year. RESULTS: The clinical follow-up will be performed for 1year after enrollment. The primary efficacy endpoint is to compare the annual stroke rate between aspirin and clopidogrel treatment groups. The primary safety endpoint is to compare the prevalence of drug-induced gastrointestinal (GI) and intracranial hemorrhage and upper-GI response including PUD based on EGD after 1year. CONCLUSIONS: This trial will determine whether clopidogrel is noninferior in stroke prevention and superior in reduction of GI events including PUD to aspirin in AF patients with low stroke risk. (ClinicalTrials.gov: NCT02960126).-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfCONTEMPORARY CLINICAL TRIALS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAspirin/administration & dosage-
dc.subject.MESHAspirin/adverse effects-
dc.subject.MESHAspirin/therapeutic use*-
dc.subject.MESHAtrial Fibrillation/complications*-
dc.subject.MESHAtrial Fibrillation/drug therapy*-
dc.subject.MESHDrug Therapy, Combination-
dc.subject.MESHEndoscopy, Digestive System-
dc.subject.MESHGastrointestinal Hemorrhage/chemically induced-
dc.subject.MESHGastrointestinal Hemorrhage/prevention & control-
dc.subject.MESHHumans-
dc.subject.MESHPlatelet Aggregation Inhibitors/administration & dosage-
dc.subject.MESHPlatelet Aggregation Inhibitors/adverse effects-
dc.subject.MESHPlatelet Aggregation Inhibitors/therapeutic use*-
dc.subject.MESHProton Pump Inhibitors/administration & dosage-
dc.subject.MESHResearch Design-
dc.subject.MESHRisk Factors-
dc.subject.MESHStroke/prevention & control*-
dc.subject.MESHTiclopidine/administration & dosage-
dc.subject.MESHTiclopidine/adverse effects-
dc.subject.MESHTiclopidine/analogs & derivatives*-
dc.subject.MESHTiclopidine/therapeutic use-
dc.titleRationale and Design for a Randomized Comparison of Efficacy and Safety between Aspirin and Clopidogrel in Atrial Fibrillation Patients with Low Stroke Risk: CESAC-AF trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorSang Min Park-
dc.contributor.googleauthorHaemin Jeong-
dc.contributor.googleauthorMi-Hyang Jung-
dc.contributor.googleauthorKyung Soon Hong-
dc.contributor.googleauthorMyeong-Ki Hong-
dc.contributor.googleauthorChang Seok Bang-
dc.contributor.googleauthorChristopher Y. Kim-
dc.identifier.doi10.1016/j.cct.2017.06.011-
dc.contributor.localIdA04391-
dc.relation.journalcodeJ00644-
dc.identifier.eissn1559-2030-
dc.identifier.pmid28642210-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S155171441730160X-
dc.subject.keywordAtrial fibrillation-
dc.subject.keywordBleeding-
dc.subject.keywordEsophagogastroduodenoscopy-
dc.subject.keywordStroke-
dc.contributor.alternativeNameHong, Myeong Ki-
dc.contributor.affiliatedAuthorHong, Myeong Ki-
dc.citation.volume60-
dc.citation.startPage51-
dc.citation.endPage55-
dc.identifier.bibliographicCitationCONTEMPORARY CLINICAL TRIALS, Vol.60 : 51-55, 2017-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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