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 100 mg or clopidogrel 75 mg for 1 year; two antiplatelet agent and proton pump inhibitor (PPI) combination groups. Follow-up EGD will be performed at 1 year. Results The clinical follow-up will be performed for 1 year 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 1 year. 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).
All Science Journal Classification (ASJC) codes
- Pharmacology (medical)