<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/NCT03765242</url>
  </required_header>
  <id_info>
    <org_study_id>CV185-698</org_study_id>
    <nct_id>NCT03765242</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Effectiveness on Oral Anticoagulants</brief_title>
  <acronym>RCR-OAC</acronym>
  <official_title>Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve&#xD;
      non-valvular atrial fibrillation (NVAF) patients initiating treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2018</start_date>
  <completion_date type="Actual">December 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of major bleeding among oral anticoagulant (OAC) initiators</measure>
    <time_frame>Maximum 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of thromboembolic events</measure>
    <time_frame>Maximum 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stoke/SE (secondary event) among OAC initiators</measure>
    <time_frame>Maximum 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr</measure>
    <time_frame>Maximum 3 years</time_frame>
    <description>CCr creatinine clearance (&lt; 50ml/min and &gt; 50ml/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cardiovascular/all cause death among OAC initiators</measure>
    <time_frame>Maximum 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of myocardial infarction among OAC initiators</measure>
    <time_frame>Maximum 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major adverse cardiac event among OAC initiators</measure>
    <time_frame>Maximum 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)</measure>
    <time_frame>Maximum 3 years</time_frame>
    <description>CCr (&lt; 50ml/min and &gt; 50ml/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of myocardial infarction among OAC initiators stratified by CCr</measure>
    <time_frame>Maximum 3 years</time_frame>
    <description>CCr (&lt; 50ml/min and &gt; 50ml/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of major adverse cardiac event among OAC initiators stratified by CCr</measure>
    <time_frame>Maximum 3 years</time_frame>
    <description>CCr (&lt; 50ml/min and &gt; 50ml/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics among OAC initiators</measure>
    <time_frame>Maximum 3 years</time_frame>
    <description>Clinical characteristics will be summarized using descriptive statistics</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12354</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Patient initiating warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient initiating apixaban</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Interventional</intervention_name>
    <description>Non-Interventional</description>
    <arm_group_label>Patient initiating apixaban</arm_group_label>
    <arm_group_label>Patient initiating warfarin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients' medical charts with newly initiating warfarin or apixaban within the&#xD;
        identification period fulfilling the study eligibility criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals greater than or equal to 20 years old as of the index date&#xD;
&#xD;
          -  At least 1 diagnosis of NVAF prior to or on index date, identified by any medical&#xD;
             records&#xD;
&#xD;
          -  Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first&#xD;
             warfarin or apixaban prescription date during the identification period will be&#xD;
             designated as the index date&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's medical records indicating pregnancy during the follow-up period&#xD;
&#xD;
          -  Patient's medical records indicating taking warfarin, apixaban, dabigatran,&#xD;
             rivaroxaban, or edoxaban during the 6-months prior to the index date&#xD;
&#xD;
          -  Had &gt; 1 OAC prescription in the patient's medical records on the index date&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>1080074</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03765242
org study id: CV185-698
nct id: NCT03765242
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve
      non-valvular atrial fibrillation (NVAF) patients initiating treatment
observational model: Cohort
time perspective: Retrospective
measure: Incidence of major bleeding among oral anticoagulant (OAC) initiators
time frame: Maximum 3 years
measure: Incidence of thromboembolic events
time frame: Maximum 3 years
measure: Incidence of stoke/SE (secondary event) among OAC initiators
time frame: Maximum 3 years
measure: Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr
time frame: Maximum 3 years
description: CCr creatinine clearance (< 50ml/min and > 50ml/min)
measure: Incidence of cardiovascular/all cause death among OAC initiators
time frame: Maximum 3 years
measure: Incidence of myocardial infarction among OAC initiators
time frame: Maximum 3 years
measure: Incidence of major adverse cardiac event among OAC initiators
time frame: Maximum 3 years
measure: Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)
time frame: Maximum 3 years
description: CCr (< 50ml/min and > 50ml/min)
measure: Incidence of myocardial infarction among OAC initiators stratified by CCr
time frame: Maximum 3 years
description: CCr (< 50ml/min and > 50ml/min)
measure: Incidence of major adverse cardiac event among OAC initiators stratified by CCr
time frame: Maximum 3 years
description: CCr (< 50ml/min and > 50ml/min)
measure: Distribution of clinical characteristics among OAC initiators
time frame: Maximum 3 years
description: Clinical characteristics will be summarized using descriptive statistics
arm group label: Patient initiating warfarin
arm group label: Patient initiating apixaban
intervention type: Other
intervention name: Non-Interventional
description: Non-Interventional
arm group label: Patient initiating apixaban
arm group label: Patient initiating warfarin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: Japan
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Atrial Fibrillation