<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/NCT01668901</url>
  </required_header>
  <id_info>
    <org_study_id>WASAK</org_study_id>
    <nct_id>NCT01668901</nct_id>
  </id_info>
  <brief_title>Warfarin Versus Aspirin in Patients With Atrial Fibrillation and Chronic Kidney Disease</brief_title>
  <official_title>A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators examine whether aspirin or warfarin is useful for atrial&#xD;
      fibrillation patients with chronic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      randomised open labelled prospective study&#xD;
&#xD;
      We enroll patients with CHADS2 score 1 non-valvular AF with chronic kidney disease, and&#xD;
      analyze all thromboembolic event or major bleeding event during follow-up period. Warfarin&#xD;
      group take dose adjusted warfarin (target INR 2.0-3.0) and aspirin group take aspirin 100mg&#xD;
      daly.&#xD;
&#xD;
      Thromboembolic events: Ischemic stroke or systemic arterial occlusion Major bleeding:&#xD;
      gastrointestinal bleeding or intracranial bleeding (code 430, code 431, code 432 by ICD-9-CM&#xD;
      codes)&#xD;
&#xD;
      -&gt; Only the first event of each case will be used for the analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Financial problem&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thromboembolic event</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Ischemis stroke and systemic thromboembolism</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>warfarin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aspirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>warfarin</intervention_name>
    <description>anticoagulation</description>
    <arm_group_label>warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>antiplatelet</description>
    <arm_group_label>aspirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CHADS2 score 1 nonvalvular atrial fibrillation patients with chronic kidney disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HAS-BLED ≥30&#xD;
&#xD;
          -  History of syncope or seizure within 1 year&#xD;
&#xD;
          -  History of major bleeding event within 6 months&#xD;
&#xD;
          -  BP&gt;180/100&#xD;
&#xD;
          -  Abnormal prothrombin time&#xD;
&#xD;
          -  Hypersensitivity of aspirin or warfarin&#xD;
&#xD;
          -  Folstein mini mental state examination score &lt;26&#xD;
&#xD;
          -  Taking or had taken other anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seil Oh, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital, Seoul , Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul Nationap University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>warfarin</keyword>
  <keyword>aspirin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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>Aspirin</mesh_term>
    <mesh_term>Warfarin</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/NCT01668901
org study id: WASAK
nct id: NCT01668901
lead sponsor: 
has dmc: No
In this study, the investigators examine whether aspirin or warfarin is useful for atrial
      fibrillation patients with chronic kidney disease.
randomised open labelled prospective study

      We enroll patients with CHADS2 score 1 non-valvular AF with chronic kidney disease, and
      analyze all thromboembolic event or major bleeding event during follow-up period. Warfarin
      group take dose adjusted warfarin (target INR 2.0-3.0) and aspirin group take aspirin 100mg
      daly.

      Thromboembolic events: Ischemic stroke or systemic arterial occlusion Major bleeding:
      gastrointestinal bleeding or intracranial bleeding (code 430, code 431, code 432 by ICD-9-CM
      codes)

      -> Only the first event of each case will be used for the analysis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Thromboembolic event
time frame: through study completion, an average of 1 year
description: Ischemis stroke and systemic thromboembolism
measure: Major bleeding
time frame: through study completion, an average of 1 year
arm group label: warfarin
arm group type: Experimental
description: medication
arm group label: aspirin
arm group type: Active Comparator
description: medication
intervention type: Drug
intervention name: warfarin
description: anticoagulation
arm group label: warfarin
intervention type: Drug
intervention name: Aspirin
description: antiplatelet
arm group label: aspirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Seil Oh, MD,PhD
role: Principal Investigator
affiliation: Seoul National University Hospital, Seoul , Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Atrial Fibrillation
mesh term: Aspirin
mesh term: Warfarin
sharing ipd: No