<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/NCT04437654</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0438</org_study_id>
    <nct_id>NCT04437654</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)</brief_title>
  <official_title>The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)</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>
      The purpose of this study is to investigate the efficacy and safety of non-vitamin K&#xD;
      antagonist oral anticoagulants (NOAC) in atrial fibrillation patients with intermediate&#xD;
      stroke risk (CHA2DS2-VASc score 1 for male, 2 for female).&#xD;
&#xD;
      A. Major safety results include major bleeding and clinically relevant non-major bleeding.&#xD;
&#xD;
      B. Major efficacy results include strokes, systemic embolism and mortality. C. Other results&#xD;
      include myocardial infarction, pulmonary embolism, transient ischemic attack,&#xD;
      hospitalization, drug compliance, quality of life questionnaire (AFEQT), cognitive function&#xD;
      (KDSQ), aging questionnaire(K-Frail) and hand grip strength.&#xD;
    </textblock>
  </brief_summary>
  <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, major bleeding, and death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>1 month</time_frame>
    <description>Composite outcome including stroke/systemic embolism, major bleeding, and death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>6 months</time_frame>
    <description>Composite outcome including stroke/systemic embolism, major bleeding, and death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>12 months</time_frame>
    <description>Composite outcome including stroke/systemic embolism, major bleeding, and death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>18 months</time_frame>
    <description>Composite outcome including stroke/systemic embolism, major bleeding, and death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite outcome</measure>
    <time_frame>24 months</time_frame>
    <description>Composite outcome including stroke/systemic embolism, major bleeding, and death</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>Systemic embolism</measure>
    <time_frame>Baseline</time_frame>
    <description>Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>1 month</time_frame>
    <description>Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>6 months</time_frame>
    <description>Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>12 months</time_frame>
    <description>Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>18 months</time_frame>
    <description>Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>24 months</time_frame>
    <description>Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.</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>1. 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: i. requiring medical intervention by a healthcare professional ii. leading to hospitalization or increased level of care iii. prompting a face to face (i.e., not just a telephone or electronic communication) evaluation 2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1: i. Fatal bleeding, and/or ii. Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or iii. Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Baseline, 1month, 6 month, 12 month, 18 month, 24 month</time_frame>
    <description>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">1800</enrollment>
  <condition>Atrial Fibrillation Patients With Intermediate Stroke Risk</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;
          -  Age: 19~80 years old&#xD;
&#xD;
          -  CHA2DS2-VASc score 1 for male or 2 for female among nonvalvular atrial fibrillation&#xD;
             patients&#xD;
&#xD;
          -  Patients who agree to register for this study&#xD;
&#xD;
          -  Patients who can be observed for the progress after treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe liver or kidney dysfunction&#xD;
&#xD;
          -  Thyroid dysfunction&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Malignant tumors that have not been completely cured&#xD;
&#xD;
          -  Severe structural heart disease&#xD;
&#xD;
          -  Predicted survival is less than 12 months&#xD;
&#xD;
          -  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 1 for male, 2 for 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</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</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>January 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>anticoagulation</keyword>
  <keyword>intermediate stroke risk</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <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/NCT04437654
org study id: 4-2020-0438
nct id: NCT04437654
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the efficacy and safety of non-vitamin K
      antagonist oral anticoagulants (NOAC) in atrial fibrillation patients with intermediate
      stroke risk (CHA2DS2-VASc score 1 for male, 2 for female).

      A. Major safety results include major bleeding and clinically relevant non-major bleeding.

      B. Major efficacy results include strokes, systemic embolism and mortality. C. Other results
      include myocardial infarction, pulmonary embolism, transient ischemic attack,
      hospitalization, drug compliance, quality of life questionnaire (AFEQT), cognitive function
      (KDSQ), aging questionnaire(K-Frail) and hand grip strength.
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, major bleeding, and death
measure: Composite outcome
time frame: 1 month
description: Composite outcome including stroke/systemic embolism, major bleeding, and death
measure: Composite outcome
time frame: 6 months
description: Composite outcome including stroke/systemic embolism, major bleeding, and death
measure: Composite outcome
time frame: 12 months
description: Composite outcome including stroke/systemic embolism, major bleeding, and death
measure: Composite outcome
time frame: 18 months
description: Composite outcome including stroke/systemic embolism, major bleeding, and death
measure: Composite outcome
time frame: 24 months
description: Composite outcome including stroke/systemic embolism, major bleeding, and death
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: Systemic embolism
time frame: Baseline
description: Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
measure: Systemic embolism
time frame: 1 month
description: Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
measure: Systemic embolism
time frame: 6 months
description: Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
measure: Systemic embolism
time frame: 12 months
description: Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
measure: Systemic embolism
time frame: 18 months
description: Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
measure: Systemic embolism
time frame: 24 months
description: Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
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: 1. 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: i. requiring medical intervention by a healthcare professional ii. leading to hospitalization or increased level of care iii. prompting a face to face (i.e., not just a telephone or electronic communication) evaluation 2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1: i. Fatal bleeding, and/or ii. Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or iii. Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.
measure: Death
time frame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
description: 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 1 for male, 2 for female.
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boyoung Joung
phone: 82-2-2228-8447
email: cby6908@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
mesh term: Atrial Fibrillation
mesh term: Apixaban
sharing ipd: No