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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

Authors
 Sang Min Park  ;  Haemin Jeong  ;  Mi-Hyang Jung  ;  Kyung Soon Hong  ;  Myeong-Ki Hong  ;  Chang Seok Bang  ;  Christopher Y. Kim 
Citation
 Contemporary Clinical Trials, Vol.60 : 51-55, 2017 
Journal Title
 Contemporary Clinical Trials 
ISSN
 1551-7144 
Issue Date
2017
MeSH
Aspirin/administration & dosage ; Aspirin/adverse effects ; Aspirin/therapeutic use* ; Atrial Fibrillation/complications* ; Atrial Fibrillation/drug therapy* ; Drug Therapy, Combination ; Endoscopy, Digestive System ; Gastrointestinal Hemorrhage/chemically induced ; Gastrointestinal Hemorrhage/prevention & control ; Humans ; Platelet Aggregation Inhibitors/administration & dosage ; Platelet Aggregation Inhibitors/adverse effects ; Platelet Aggregation Inhibitors/therapeutic use* ; Proton Pump Inhibitors/administration & dosage ; Research Design ; Risk Factors ; Stroke/prevention & control* ; Ticlopidine/administration & dosage ; Ticlopidine/adverse effects ; Ticlopidine/analogs & derivatives* ; Ticlopidine/therapeutic use
Keywords
Atrial fibrillation ; Bleeding ; Esophagogastroduodenoscopy ; Stroke
Abstract
BACKGROUND: 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).
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/160945
DOI
10.1016/j.cct.2017.06.011
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
홍명기(Hong, Myeong Ki)
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Full Text
https://www.sciencedirect.com/science/article/pii/S155171441730160X
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