Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk (CESAC-AF)
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|ClinicalTrials.gov Identifier: NCT02960126|
Recruitment Status : Not yet recruiting
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Chuncheon Sacred Heart Hospital
Information provided by (Responsible Party):
Sang Min Park, Chuncheon Sacred Heart Hospital
This study was designed in order to evaluate and compare the efficacy and safety between aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Aspirin Drug: Clopidogrel||Phase 3|
Efficacy outcome will be evaluated the major cerebro-cardiovascular event including stroke, cardiovascular death, and myocardial infarction during 1 year-medication period. In addition, safety outcome will be evaluated the gastrointestinal responses including peptic ulcer and upper gastrointestinal bleeding events to both study drugs by repeated gastroenteroscopic examinations before and after medication by GI specialist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
Active Comparator: Intervention: Clopidogrel
Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Experimental: Control: Aspirin
Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Primary Outcome Measures :
- Major Cerebrovascular and cardiac events including stroke, CV death, MI [ Time Frame: 1 year after randomization ]Number of each event
- Major gastrointestinal event including peptic ulcer disease and bleeding [ Time Frame: 1 year after randomization ]Number of each event
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