<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/NCT03242278</url>
  </required_header>
  <id_info>
    <org_study_id>18733</org_study_id>
    <secondary_id>XA1511US</secondary_id>
    <nct_id>NCT03242278</nct_id>
  </id_info>
  <brief_title>Real-world Dosing Patterns of Rivaroxaban in the United States</brief_title>
  <official_title>Real-world Dosing Patterns of Rivaroxaban in the United States (RIVA-D)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</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>
      The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF)&#xD;
      patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of&#xD;
      rivaroxaban.&#xD;
&#xD;
      The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced&#xD;
      by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal&#xD;
      function).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2016</start_date>
  <completion_date type="Actual">March 1, 2016</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</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>Number of NVAF patients receiving 20 mg Rivaroxaban</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of NVAF patients receiving 15 mg Rivaroxaban</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline renal function</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12507</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>NVAF patients receiving 20 mg rivaroxaban</arm_group_label>
    <description>NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NVAF patients receiving 15 mg rivaroxaban</arm_group_label>
    <description>NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>As prescribed by treating physicians</description>
    <arm_group_label>NVAF patients receiving 15 mg rivaroxaban</arm_group_label>
    <arm_group_label>NVAF patients receiving 20 mg rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with non-valvular atrial fibrillation (NVAF)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NVAF (non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more&#xD;
             inpatient or outpatient claims with International Classification of Disease ICD-9&#xD;
             427.31 as the diagnosis code at any time in the patient's data history prior to&#xD;
             inclusion&#xD;
&#xD;
          -  Patients will be required to have 180 days of enrollment for the assessment of&#xD;
             baseline characteristics&#xD;
&#xD;
          -  CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline&#xD;
             period&#xD;
&#xD;
          -  Evidence of continuous enrollment in MarketScan during 180 days before the date of the&#xD;
             first prescription of rivaroxaban&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18 years of age&#xD;
&#xD;
          -  Patients with valvular AF (atrial fibrillation)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Malignant cancers&#xD;
&#xD;
          -  Transient cause of AF&#xD;
&#xD;
          -  Patients with VTE (Venous thromboembolism), pulmonary embolism or DVT (Deep Vein&#xD;
             Thrombosis)&#xD;
&#xD;
          -  Patients with major surgery defined as hip or knee replacement&#xD;
&#xD;
          -  Prescriptions of OACs (Oral anticoagulants) (apixaban,warfarin, dabigatran,&#xD;
             rivaroxaban) before index date&#xD;
&#xD;
          -  Prescription of more than one OAC on the index 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>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-valvular atrial fibrillation (NVAF)</keyword>
  <keyword>Prevention</keyword>
  <keyword>Stroke</keyword>
  <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>Rivaroxaban</mesh_term>
  </intervention_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/NCT03242278
org study id: 18733
secondary id: XA1511US
nct id: NCT03242278
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF)
      patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of
      rivaroxaban.

      The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced
      by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal
      function).
observational model: Cohort
time perspective: Retrospective
measure: Number of NVAF patients receiving 20 mg Rivaroxaban
time frame: At baseline
measure: Number of NVAF patients receiving 15 mg Rivaroxaban
time frame: At baseline
measure: Baseline renal function
time frame: At baseline
arm group label: NVAF patients receiving 20 mg rivaroxaban
description: NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)
arm group label: NVAF patients receiving 15 mg rivaroxaban
description: NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: As prescribed by treating physicians
arm group label: NVAF patients receiving 15 mg rivaroxaban
arm group label: NVAF patients receiving 20 mg rivaroxaban
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Rivaroxaban