Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
CESAC-AF
Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
1 other identifier
interventional
1,500
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Nov 2016
Longer than P75 for phase_3 atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 2, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedNovember 9, 2016
November 1, 2016
3.9 years
November 2, 2016
November 8, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Major Cerebrovascular and cardiac events including stroke, CV death, MI
Number of each event
1 year after randomization
Major gastrointestinal event including peptic ulcer disease and bleeding
Number of each event
1 year after randomization
Study Arms (2)
Intervention: Clopidogrel
ACTIVE COMPARATORCase management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Control: Aspirin
EXPERIMENTALUsual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28642210DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 2, 2016
First Posted
November 9, 2016
Study Start
November 1, 2016
Primary Completion
October 1, 2020
Study Completion
October 1, 2021
Last Updated
November 9, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share