<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/NCT03254134</url>
  </required_header>
  <id_info>
    <org_study_id>1160-0288</org_study_id>
    <nct_id>NCT03254134</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness and Safety Between Warfarin and Dabigatran</brief_title>
  <official_title>Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a comparative effectiveness and safety study of clinical events among patients taking&#xD;
      either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to&#xD;
      provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and&#xD;
      bleeding events (safety) using 95% confidence interval for comparison between those&#xD;
      non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large,&#xD;
      nation-wide claims data in Japan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a comparative effectiveness and safety study of clinical events among patients taking&#xD;
      either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to&#xD;
      provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and&#xD;
      bleeding events (safety) using 95% confidence interval for comparison between those&#xD;
      non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large,&#xD;
      nation-wide claims data in Japan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">November 3, 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>Incidence Rate of Stroke and Systemic Embolism (SE)</measure>
    <time_frame>From the index date to end of treatment with &gt; 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.</time_frame>
    <description>Incidence rate of stroke and systemic embolism (SE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence Rate of Major Bleeding</measure>
    <time_frame>From the index date to end of treatment with &gt; 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.</time_frame>
    <description>Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22490</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
    <description>patients with atrial fibrillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin</intervention_name>
    <description>patients treated with warfarin</description>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran</intervention_name>
    <description>patients treated with Dabigatran</description>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
    <other_name>PRADAXA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patients with atrial fibrillation contained in the Medical Data Vision (MDVI) 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;
          -  patients aged &gt;18 year-old with confirmed diagnosis of Non-Valvular Atrial&#xD;
             Fibrillation (NVAF) (ICD 10 code I48)&#xD;
&#xD;
          -  having a first prescription (index date) of either dabigatran or warfarin between 14&#xD;
             March 2011 to 30 June 2016&#xD;
&#xD;
          -  having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the&#xD;
             index date (this period is defined as the baseline period)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients having less than 12 months of enrolment prior to the index date&#xD;
&#xD;
          -  being dialysis or kidney transplant recipients in baseline period&#xD;
&#xD;
          -  having either atrial flutter, valvular atrial fibrillation (AF)&#xD;
&#xD;
          -  mechanical valve placement, rheumatic AF&#xD;
&#xD;
          -  and/or mitral valve prolapse/regurge/stenosis in baseline period&#xD;
&#xD;
          -  having record of deep vein thrombosis or pulmonary embolism &lt; 6 months before AF&#xD;
             diagnosis in baseline period&#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>July 2019</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 30, 2018</results_first_submitted>
  <results_first_submitted_qc>July 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2019</results_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 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>Dabigatran</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03254134/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.</recruitment_details>
      <pre_assignment_details>The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) and newly treated with dabigatran and warfarin in the real world Japanese setting between April 2010 and June 2016 using the Medical Data Vision (MDV) database.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran</title>
          <description>Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
        </group>
        <group group_id="P2">
          <title>Warfarin</title>
          <description>Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5745"/>
                <participants group_id="P2" count="16745"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5146"/>
                <participants group_id="P2" count="13115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="599"/>
                <participants group_id="P2" count="3630"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not eligible patients</title>
              <participants_list>
                <participants group_id="P1" count="599"/>
                <participants group_id="P2" count="3630"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Eligible patients who were prescribed dabigatran and warfarin as the first OACs</population>
      <group_list>
        <group group_id="B1">
          <title>Dabigatran</title>
          <description>Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
        </group>
        <group group_id="B2">
          <title>Warfarin</title>
          <description>Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5146"/>
            <count group_id="B2" value="13115"/>
            <count group_id="B3" value="18261"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Eligible patients who were prescribed dabigatran and warfarin as the first OACs</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5146"/>
                    <count group_id="B2" value="13115"/>
                    <count group_id="B3" value="18261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="10"/>
                    <measurement group_id="B2" value="78" spread="10"/>
                    <measurement group_id="B3" value="76" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Eligible patients who were prescribed dabigatran and warfarin as the first OACs</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5146"/>
                    <count group_id="B2" value="13115"/>
                    <count group_id="B3" value="18261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1695"/>
                    <measurement group_id="B2" value="5294"/>
                    <measurement group_id="B3" value="6989"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3451"/>
                    <measurement group_id="B2" value="7821"/>
                    <measurement group_id="B3" value="11272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Stroke and Systemic Embolism (SE)</title>
        <description>Incidence rate of stroke and systemic embolism (SE).</description>
        <time_frame>From the index date to end of treatment with &gt; 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.</time_frame>
        <population>Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
          </group>
          <group group_id="O2">
            <title>Warfarin</title>
            <description>Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Stroke and Systemic Embolism (SE)</title>
          <description>Incidence rate of stroke and systemic embolism (SE).</description>
          <population>Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).</population>
          <units>per patient-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4606"/>
                <count group_id="O2" value="4606"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.898"/>
                    <measurement group_id="O2" value="3.563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>There was no formal hypothesis testing.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.720</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.534</ci_lower_limit>
            <ci_upper_limit>0.970</ci_upper_limit>
            <other_analysis_desc>The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence Rate of Major Bleeding</title>
        <description>Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.</description>
        <time_frame>From the index date to end of treatment with &gt; 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.</time_frame>
        <population>Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
          </group>
          <group group_id="O2">
            <title>Warfarin</title>
            <description>Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Major Bleeding</title>
          <description>Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.</description>
          <population>Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).</population>
          <units>per patient-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4606"/>
                <count group_id="O2" value="4606"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.639"/>
                    <measurement group_id="O2" value="1.128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>There was no formal hypothesis testing.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.549</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.303</ci_lower_limit>
            <ci_upper_limit>0.994</ci_upper_limit>
            <other_analysis_desc>The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>This is a cohort study using based on existing data; therefore, it is not feasible to make a causality assessment at the individual case level.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran</title>
          <description>Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</description>
        </group>
        <group group_id="E2">
          <title>Warfarin</title>
          <description>Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.</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"/>
                <counts group_id="E2" 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"/>
                <counts group_id="E2" 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"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <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/NCT03254134
org study id: 1160-0288
nct id: NCT03254134
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a comparative effectiveness and safety study of clinical events among patients taking
      either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to
      provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and
      bleeding events (safety) using 95% confidence interval for comparison between those
      non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large,
      nation-wide claims data in Japan.
This is a comparative effectiveness and safety study of clinical events among patients taking
      either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to
      provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and
      bleeding events (safety) using 95% confidence interval for comparison between those
      non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large,
      nation-wide claims data in Japan.
observational model: Cohort
time perspective: Retrospective
measure: Incidence Rate of Stroke and Systemic Embolism (SE)
time frame: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
description: Incidence rate of stroke and systemic embolism (SE).
measure: Incidence Rate of Major Bleeding
time frame: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.
description: Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
arm group label: Atrial Fibrillation
description: patients with atrial fibrillation
intervention type: Drug
intervention name: Warfarin
description: patients treated with warfarin
arm group label: Atrial Fibrillation
intervention type: Drug
intervention name: Dabigatran
description: patients treated with Dabigatran
arm group label: Atrial Fibrillation
other name: PRADAXA
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: Dabigatran
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 