<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/NCT03002740</url>
  </required_header>
  <id_info>
    <org_study_id>CV185-491</org_study_id>
    <nct_id>NCT03002740</nct_id>
  </id_info>
  <brief_title>Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation</brief_title>
  <official_title>Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with&#xD;
      oral anticoagulants (OAC) in routine clinical practice in England, this study will describe&#xD;
      patients treated with each OAC, and to estimate and compare event rates of treatment&#xD;
      discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">January 31, 2016</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</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>Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)</measure>
    <time_frame>Approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)</measure>
    <time_frame>Approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)</measure>
    <time_frame>Approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)</measure>
    <time_frame>Approximately 3 years</time_frame>
    <description>Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-valvular Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>NVAF patients newly prescribed apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>NVAF patients newly prescribed rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>NVAF patients newly prescribed dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>NVAF patients newly prescribed VKA</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with NVAF recorded in the UK Clinical Practice Research Datalink(CPRD) and Hospital&#xD;
        Episode Statistics(HES) database, and who were newly prescribed with apixaban, rivaroxaban,&#xD;
        dabigatran or VKA from 1st December 2012 and 31st December 2015 (or up to the most recent&#xD;
        data available).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study&#xD;
             period&#xD;
&#xD;
          2. Are ≥ 18 years of age at index date&#xD;
&#xD;
          3. Have ≥ 12 months of computerised medical data prior to index date (date of OAC&#xD;
             initiation)&#xD;
&#xD;
          4. Have a record of AF on or ever prior to index date&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a record for a valvular condition that is considered causal for AF on or ever&#xD;
             prior to index date&#xD;
&#xD;
          2. Have a history of the OACs which are prescribed during the study period (ie, history&#xD;
             of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban,&#xD;
             dabigatran, or VKA)&#xD;
&#xD;
          3. Have more than 1 OAC exposure which starts on the same date&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2018</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/NCT03002740
org study id: CV185-491
nct id: NCT03002740
lead sponsor: 
collaborator: 
has dmc: No
In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with
      oral anticoagulants (OAC) in routine clinical practice in England, this study will describe
      patients treated with each OAC, and to estimate and compare event rates of treatment
      discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.
observational model: Cohort
time perspective: Retrospective
measure: Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
time frame: Approximately 3 years
measure: Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
time frame: At baseline
measure: Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)
time frame: At baseline
measure: Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
time frame: Approximately 3 years
measure: Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)
time frame: Approximately 3 years
measure: Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)
time frame: Approximately 3 years
description: Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests
arm group label: NVAF patients newly prescribed apixaban
arm group label: NVAF patients newly prescribed rivaroxaban
arm group label: NVAF patients newly prescribed dabigatran
arm group label: NVAF patients newly prescribed VKA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
responsible party type: Sponsor
mesh term: Atrial Fibrillation