<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432220</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0391</org_study_id>
    <nct_id>NCT04432220</nct_id>
  </id_info>
  <brief_title>AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)</brief_title>
  <official_title>AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There has no evidence for the anticoagulation in patients who had undergone catheter ablation&#xD;
      of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However,&#xD;
      anticoagulation can increase the risk of bleeding, the study evaluating the role of oral&#xD;
      anticoagulation is needed in this patients. This study will compare the efficacy and safety&#xD;
      of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus&#xD;
      rhythm one year after catheter ablation of AF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective randomized study which was performed in multicenter (General&#xD;
      Hospital) in Korea. Inclusion criteria is atrial fibrillation patients with moderate or high&#xD;
      stroke risk (CHA2DS2-VASc&gt;=1 male, and &gt;=2 female) who had undergone catheter ablation of&#xD;
      atrial fibrillation, and has maintained sinus rhythm for more than 1 year. Anticoagulation&#xD;
      (Apixaban group) will take apixaban (5 mg bid or 2.5 mg bid according to dose guideline) for&#xD;
      2 years, and nonanticoagulation group will not take any oral anticoagulants for the same&#xD;
      period. If the patients have the recurrence of AF, they will take anticoagulation according&#xD;
      to standard treatment, and will be censored. We will analyze and compare the efficacy and&#xD;
      safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in these&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">October 2028</completion_date>
  <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>Baseline</time_frame>
    <description>composite outcome including stroke/systemic embolism and major bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>1 month</time_frame>
    <description>composite outcome including stroke/systemic embolism and major bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>6 months</time_frame>
    <description>composite outcome including stroke/systemic embolism and major bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>12 months</time_frame>
    <description>composite outcome including stroke/systemic embolism and major bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>18 months</time_frame>
    <description>composite outcome including stroke/systemic embolism and major bleeding</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>24 months</time_frame>
    <description>composite outcome including stroke/systemic embolism and major bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>Baseline</time_frame>
    <description>Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1 month</time_frame>
    <description>Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>6 months</time_frame>
    <description>Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>12 months</time_frame>
    <description>Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>18 months</time_frame>
    <description>Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>24 months</time_frame>
    <description>Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>Baseline</time_frame>
    <description>The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.&#xD;
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>1 month</time_frame>
    <description>The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.&#xD;
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>6 months</time_frame>
    <description>The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.&#xD;
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>12 months</time_frame>
    <description>The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.&#xD;
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>18 months</time_frame>
    <description>The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.&#xD;
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>24 months</time_frame>
    <description>The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.&#xD;
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Relivant Non-Major Bleeding (CRNMB)</measure>
    <time_frame>Baseline, 1month, 6 month, 12 month, 18 month, 24 month</time_frame>
    <description>- Clinically Relivant Non-Major Bleeding (CRNMB) :&#xD;
Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:&#xD;
ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Baseline, 1month, 6 month, 12 month, 18 month, 24 month</time_frame>
    <description>Death: the permanent stopping of all the vital bodily activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transient ischemic attack (TIA)</measure>
    <time_frame>Baseline, 1month, 6 month, 12 month, 18 month, 24 month</time_frame>
    <description>TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission</measure>
    <time_frame>Baseline, 1month, 6 month, 12 month, 18 month, 24 month</time_frame>
    <description>Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">840</enrollment>
  <condition>Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Anticoagulation group(Apixaban group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonanticoagulation group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment except anticoagulant for 2 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anticoagulation group(Apixaban group)</intervention_name>
    <description>Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years</description>
    <arm_group_label>Anticoagulation group(Apixaban group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. no recurrence of atrial fibrillation one year after catheter ablation of atrial&#xD;
             fibrillation&#xD;
&#xD;
          2. CHA2DS2-VASc score &gt;=1 (male) or &gt;=2 (female)&#xD;
&#xD;
          3. age: 19 to 80 years&#xD;
&#xD;
          4. non-valvular atrial fibrillation&#xD;
&#xD;
          5. those who consent the study.&#xD;
&#xD;
          6. those who can be followed after enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe liver or kidney dysfunction&#xD;
&#xD;
          2. Thyroid dysfunction&#xD;
&#xD;
          3. Pregnant or breastfeeding women&#xD;
&#xD;
          4. Malignant tumors that have not been completely cured&#xD;
&#xD;
          5. Severe structural heart disease&#xD;
&#xD;
          6. Predicted survival is less than 12 months&#xD;
&#xD;
          7. Patients who do not understand the content of the study or disagree with it&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>CHA2DS2-VASc score over 1point male or CHA2DS2-VASc score over 2points female.</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Boyoung Joung, Ph.D</last_name>
    <phone>82-2-2228-8447</phone>
    <email>cby6908@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Severance Cardiovascular Hospital Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boyoung Joung, Ph.D</last_name>
      <phone>82-2-2228-8447</phone>
      <email>cby6908@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catheter ablation</keyword>
  <keyword>anticoagulation</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apixaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432220
org study id: 4-2020-0391
nct id: NCT04432220
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There has no evidence for the anticoagulation in patients who had undergone catheter ablation
      of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However,
      anticoagulation can increase the risk of bleeding, the study evaluating the role of oral
      anticoagulation is needed in this patients. This study will compare the efficacy and safety
      of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus
      rhythm one year after catheter ablation of AF.
This study is a prospective randomized study which was performed in multicenter (General
      Hospital) in Korea. Inclusion criteria is atrial fibrillation patients with moderate or high
      stroke risk (CHA2DS2-VASc>=1 male, and >=2 female) who had undergone catheter ablation of
      atrial fibrillation, and has maintained sinus rhythm for more than 1 year. Anticoagulation
      (Apixaban group) will take apixaban (5 mg bid or 2.5 mg bid according to dose guideline) for
      2 years, and nonanticoagulation group will not take any oral anticoagulants for the same
      period. If the patients have the recurrence of AF, they will take anticoagulation according
      to standard treatment, and will be censored. We will analyze and compare the efficacy and
      safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in these
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite outcome
time frame: Baseline
description: composite outcome including stroke/systemic embolism and major bleeding
measure: Composite outcome
time frame: 1 month
description: composite outcome including stroke/systemic embolism and major bleeding
measure: Composite outcome
time frame: 6 months
description: composite outcome including stroke/systemic embolism and major bleeding
measure: Composite outcome
time frame: 12 months
description: composite outcome including stroke/systemic embolism and major bleeding
measure: Composite outcome
time frame: 18 months
description: composite outcome including stroke/systemic embolism and major bleeding
measure: Composite outcome
time frame: 24 months
description: composite outcome including stroke/systemic embolism and major bleeding
measure: Stroke
time frame: Baseline
description: Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
measure: Stroke
time frame: 1 month
description: Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
measure: Stroke
time frame: 6 months
description: Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
measure: Stroke
time frame: 12 months
description: Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
measure: Stroke
time frame: 18 months
description: Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
measure: Stroke
time frame: 24 months
description: Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
measure: Major bleeding
time frame: Baseline
description: The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Major bleeding
time frame: 1 month
description: The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Major bleeding
time frame: 6 months
description: The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Major bleeding
time frame: 12 months
description: The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Major bleeding
time frame: 18 months
description: The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Major bleeding
time frame: 24 months
description: The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Clinically Relivant Non-Major Bleeding (CRNMB)
time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
description: - Clinically Relivant Non-Major Bleeding (CRNMB) :
Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1:
measure: Death
time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
description: Death: the permanent stopping of all the vital bodily activities
measure: Transient ischemic attack (TIA)
time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
description: TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.
measure: Hospital admission
time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
description: Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury.
arm group label: Anticoagulation group(Apixaban group)
arm group type: Experimental
description: Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
arm group label: Nonanticoagulation group
arm group type: No Intervention
description: Standard treatment except anticoagulant for 2 years
intervention type: Drug
intervention name: Anticoagulation group(Apixaban group)
description: Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
arm group label: Anticoagulation group(Apixaban group)
criteria: 
gender: All
gender based: Yes
gender description: CHA2DS2-VASc score over 1point male or CHA2DS2-VASc score over 2points female.
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boyoung Joung, Ph.D
phone: 82-2-2228-8447
email: cby6908@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Apixaban
sharing ipd: No