Back to resultsEfficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk (CESAC-AF)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Aspirin
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Man or Women > 20 years old
- newly detected AF (CHA2DS2VASc index score: 1)
- Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
- volunteer only
- childbearing aged women who takes proper oral contraceptive
Exclusion Criteria:
- No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
- Patient with active GI bleeding or bleeding tendency or major bleeding history
- less than 1 year of residual expected life
- Pregnant or breast-feeding women
- Other causes, determined by charged physician
- Patient with definite GERD who needs special treatment
- Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intervention: Clopidogrel
Control: Aspirin
Arm Description
Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Outcomes
Primary Outcome Measures
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Number of each event
Major gastrointestinal event including peptic ulcer disease and bleeding
Number of each event
Secondary Outcome Measures
Full Information
NCT ID
NCT02960126
First Posted
November 2, 2016
Last Updated
November 8, 2016
Sponsor
Chuncheon Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02960126
Brief Title
Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
Acronym
CESAC-AF
Official Title
Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chuncheon Sacred Heart Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Clopidogrel
Arm Type
Active Comparator
Arm Description
Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Arm Title
Control: Aspirin
Arm Type
Experimental
Arm Description
Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Primary Outcome Measure Information:
Title
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Description
Number of each event
Time Frame
1 year after randomization
Title
Major gastrointestinal event including peptic ulcer disease and bleeding
Description
Number of each event
Time Frame
1 year after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man or Women > 20 years old
newly detected AF (CHA2DS2VASc index score: 1)
Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
volunteer only
childbearing aged women who takes proper oral contraceptive
Exclusion Criteria:
No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
Patient with active GI bleeding or bleeding tendency or major bleeding history
less than 1 year of residual expected life
Pregnant or breast-feeding women
Other causes, determined by charged physician
Patient with definite GERD who needs special treatment
Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28642210
Citation
Park SM, Jeong H, Jung MH, Hong KS, Hong MK, Bang CS, Kim CY. 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. Contemp Clin Trials. 2017 Sep;60:51-55. doi: 10.1016/j.cct.2017.06.011. Epub 2017 Jun 19.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
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