<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/NCT03254147</url>
  </required_header>
  <id_info>
    <org_study_id>1321-0022</org_study_id>
    <nct_id>NCT03254147</nct_id>
  </id_info>
  <brief_title>Medical Need of OAC Reversal</brief_title>
  <official_title>Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the Study Number Begins With 1321; the Study Contains Only Patients Treated With OACs, Namely Warfarin, Dabigatran, Edoxaban, Apixaban, Rivaroxaban, Edoxaban)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a retrospective, observational, claims cohort study to assess, for adult patients&#xD;
      initiating an oral anticoagulant for NVAF&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective, observational, claims cohort study to assess, for adult patients&#xD;
      initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major&#xD;
      bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age&#xD;
      (&lt;64, 65-74, &gt;75). The secondary objective is to estimate the overall and age stratified&#xD;
      incidence of cardiac tamponade and peri-cardiocentesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">November 10, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</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>The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.</measure>
    <time_frame>One year</time_frame>
    <description>The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Patients With Cardiac Tamponade and Pericardiocentesis.</measure>
    <time_frame>One year</time_frame>
    <description>The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53969</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>patients prescribed with Oral Anti-coagulants</arm_group_label>
    <description>warfarin and non-vitamin K dependent oral anti-coagulants</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>warfarin</intervention_name>
    <description>warfarin</description>
    <arm_group_label>patients prescribed with Oral Anti-coagulants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dabigatran</intervention_name>
    <description>Non-vitamin K dependent oral anti-coagulants (NOACs)</description>
    <arm_group_label>patients prescribed with Oral Anti-coagulants</arm_group_label>
    <other_name>PRADAXA, PRAZAXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban</intervention_name>
    <description>Non-vitamin K dependent oral anti-coagulants (NOACs)</description>
    <arm_group_label>patients prescribed with Oral Anti-coagulants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Edoxaban</intervention_name>
    <description>Non-vitamin K dependent oral anti-coagulants (NOACs)</description>
    <arm_group_label>patients prescribed with Oral Anti-coagulants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban</intervention_name>
    <description>Non-vitamin K dependent oral anti-coagulants (NOACs)</description>
    <arm_group_label>patients prescribed with Oral Anti-coagulants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patients with atrial fibrillation contained in the Medical Data Vision (MDV) database&#xD;
        which is a Japanese, nationwide claims data containing approximately 16 million patients&#xD;
        cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV&#xD;
        database are those who have visited DPC hospitals (diagnostic procedure combination, a&#xD;
        lump-sum payment system based on disease diagnosis to be treated similar to&#xD;
        Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as&#xD;
        outpatient care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&gt;18 year old non-valvular atrial fibrillation (NVAF) patients&#xD;
&#xD;
          -  Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin&#xD;
&#xD;
          -  Patients with confirmed date of initiation of OACs&#xD;
&#xD;
          -  Patients with a minimum of 6 months of enrolment data prior to index date&#xD;
&#xD;
          -  Has an index date between 14th of March 2011 to 30 June, 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving two or more oral anti-coagulants at the same time at index date&#xD;
&#xD;
          -  Patients with prescriptions of index treatment in the 6 months prior to index date&#xD;
&#xD;
          -  Patients without enrolment period of at least six month in the database&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nippon Boehringer Ingelheim Co., Ltd.</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <results_first_submitted>October 31, 2018</results_first_submitted>
  <results_first_submitted_qc>October 31, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 4, 2019</results_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2019</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
    <mesh_term>Apixaban</mesh_term>
    <mesh_term>Edoxaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03254147/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Non-interventional study based on existing health insurance claims data</recruitment_details>
      <pre_assignment_details>All patients were screened for eligibility to participate in the trial. Patients met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Patients Prescribed With Non-warfarin Oral Anti Coagulants</title>
          <description>Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53969">The number of patients meeting the inclusion and exclusion criteria</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53969"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Patients Prescribed With Non-warfarin Oral Anti Coagulants</title>
          <description>Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53969"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21587"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53969"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Baseline characteristics are based on the number of patients meeting the inclusion and exclusion criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53969"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.</title>
        <description>The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.</description>
        <time_frame>One year</time_frame>
        <population>Results are based on the number of patients meeting the inclusion and exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Prescribed With Non-warfarin Oral Anti Coagulants</title>
            <description>Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.</title>
          <description>The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.</description>
          <population>Results are based on the number of patients meeting the inclusion and exclusion criteria.</population>
          <units>Number of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53969"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age &lt;=64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6960"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 65-74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14568"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;=75</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32441"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Patients With Cardiac Tamponade and Pericardiocentesis.</title>
        <description>The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.</description>
        <time_frame>One year</time_frame>
        <population>Results are based on the number of patients meeting the inclusion and exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients Prescribed With Non-warfarin Oral Anti Coagulants</title>
            <description>Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Cardiac Tamponade and Pericardiocentesis.</title>
          <description>The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.</description>
          <population>Results are based on the number of patients meeting the inclusion and exclusion criteria.</population>
          <units>Number of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53969"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>No adverse event reporting was done.</time_frame>
      <desc>This is a cohort study based on existing data; therefore, it is not feasible to make a causality assessment at the individual case level. Hence no adverse event reporting was done.</desc>
      <group_list>
        <group group_id="E1">
          <title>Patients Prescribed With Non-warfarin Oral Anti Coagulants</title>
          <description>Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The findings from this study may not be generalizable to other Japanese population outside of Diagnosis Procedure Combination (DPC) hospitals. All information of each patient is from consent giving DPC hospitals.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03254147
org study id: 1321-0022
nct id: NCT03254147
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective, observational, claims cohort study to assess, for adult patients
      initiating an oral anticoagulant for NVAF
This is a retrospective, observational, claims cohort study to assess, for adult patients
      initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major
      bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age
      (<64, 65-74, >75). The secondary objective is to estimate the overall and age stratified
      incidence of cardiac tamponade and peri-cardiocentesis.
observational model: Cohort
time perspective: Retrospective
measure: The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
time frame: One year
description: The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.
measure: The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
time frame: One year
description: The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.
arm group label: patients prescribed with Oral Anti-coagulants
description: warfarin and non-vitamin K dependent oral anti-coagulants
intervention type: Drug
intervention name: warfarin
description: warfarin
arm group label: patients prescribed with Oral Anti-coagulants
intervention type: Drug
intervention name: dabigatran
description: Non-vitamin K dependent oral anti-coagulants (NOACs)
arm group label: patients prescribed with Oral Anti-coagulants
other name: PRADAXA, PRAZAXA
intervention type: Drug
intervention name: Apixaban
description: Non-vitamin K dependent oral anti-coagulants (NOACs)
arm group label: patients prescribed with Oral Anti-coagulants
intervention type: Drug
intervention name: Edoxaban
description: Non-vitamin K dependent oral anti-coagulants (NOACs)
arm group label: patients prescribed with Oral Anti-coagulants
intervention type: Drug
intervention name: Rivaroxaban
description: Non-vitamin K dependent oral anti-coagulants (NOACs)
arm group label: patients prescribed with Oral Anti-coagulants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Warfarin
mesh term: Rivaroxaban
mesh term: Dabigatran
mesh term: Apixaban
mesh term: Edoxaban
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The findings from this study may not be generalizable to other Japanese population outside of Diagnosis Procedure Combination (DPC) hospitals. All information of each patient is from consent giving DPC hospitals.
point of contact: 