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Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk (CESAC-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02960126
Recruitment Status : Not yet recruiting
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):
Sang Min Park, Chuncheon Sacred Heart Hospital

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Aspirin Drug: Clopidogrel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intervention: Clopidogrel
Case management with clopidogrel 75mg once daily is provided for stroke prevention in AF patient.
Drug: Clopidogrel
Experimental: Control: Aspirin
Usual care with aspirin 100mg once daily is provided for stroke prevention in AF patient.
Drug: Aspirin

Primary Outcome Measures :
  1. Major Cerebrovascular and cardiac events including stroke, CV death, MI [ Time Frame: 1 year after randomization ]
    Number of each event

  2. Major gastrointestinal event including peptic ulcer disease and bleeding [ Time Frame: 1 year after randomization ]
    Number of each event

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Man or Women > 20 years old
  2. newly detected AF (CHA2DS2VASc index score: 1)
  3. Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
  4. volunteer only
  5. childbearing aged women who takes proper oral contraceptive

Exclusion Criteria:

  1. No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
  2. Patient with active GI bleeding or bleeding tendency or major bleeding history
  3. less than 1 year of residual expected life
  4. Pregnant or breast-feeding women
  5. Other causes, determined by charged physician
  6. Patient with definite GERD who needs special treatment
  7. Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sang Min Park, Professor, Chuncheon Sacred Heart Hospital Identifier: NCT02960126    
Other Study ID Numbers: CESAC-AF
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neurotransmitter Agents