<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/NCT02210819</url>
  </required_header>
  <id_info>
    <org_study_id>17237</org_study_id>
    <secondary_id>XA1402</secondary_id>
    <nct_id>NCT02210819</nct_id>
  </id_info>
  <brief_title>Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy</brief_title>
  <acronym>XALIA LEA</acronym>
  <official_title>XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Following the findings of the clinical trials in drug development, this global&#xD;
      non-interventional cohort field study will investigate rivaroxaban under clinical practice&#xD;
      conditions in comparison with current standard of care for patients with acute venous&#xD;
      thoromboembolism (VTE).&#xD;
&#xD;
      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of&#xD;
      acute VTE in routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2014</start_date>
  <completion_date type="Actual">January 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 3, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of major bleedings defined as overt bleeding</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Major bleedings defined as overt bleeding are associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with symptomatic recurrent venous thromboembolic events</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse cardiovascular events</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with other symptomatic thromboembolic events</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction (patient reported outcomes)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1987</enrollment>
  <condition>Deep Vein Thrombosis (DVT)</condition>
  <condition>Pulmonary Embolism (PE)</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <description>Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>Cohort participants are classified as &quot;rivaroxaban&quot; patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine</description>
    <arm_group_label>Rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recommended VTE pharmacological treatments according to international guidelines</intervention_name>
    <description>Cohort participants are classified as &quot;Standard of care&quot; patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In- and outpatients in sites participating in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male patients, who are at &gt;=18 years&#xD;
&#xD;
          -  Diagnosis of acute DVT and/or PE, objectively confirmed&#xD;
&#xD;
          -  Indication for anticoagulation therapy for at least 12 weeks&#xD;
&#xD;
          -  Willing to participate in this study and available for follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria must be read in conjunction with the local product information.&#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>Multiple Locations</city>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Kuwait</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Qatar</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Egypt</country>
    <country>Indonesia</country>
    <country>Jordan</country>
    <country>Kazakhstan</country>
    <country>Kenya</country>
    <country>Korea, Republic of</country>
    <country>Kuwait</country>
    <country>Lebanon</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Morocco</country>
    <country>Philippines</country>
    <country>Qatar</country>
    <country>Russian Federation</country>
    <country>Saudi Arabia</country>
    <country>Singapore</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>May 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thromboembolism</keyword>
  <keyword>Embolism and Thrombosis</keyword>
  <keyword>Vascular Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT02210819
org study id: 17237
secondary id: XA1402
nct id: NCT02210819
lead sponsor: 
collaborator: 
has dmc: No
Following the findings of the clinical trials in drug development, this global
      non-interventional cohort field study will investigate rivaroxaban under clinical practice
      conditions in comparison with current standard of care for patients with acute venous
      thoromboembolism (VTE).

      The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of
      acute VTE in routine clinical practice.
observational model: Cohort
time perspective: Prospective
measure: Number of major bleedings defined as overt bleeding
time frame: Up to 2 years
description: Major bleedings defined as overt bleeding are associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site
measure: Number of patients with symptomatic recurrent venous thromboembolic events
time frame: Up to 2 years
measure: All cause mortality
time frame: Up to 2 years
measure: Number of adverse cardiovascular events
time frame: Up to 2 years
description: Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.
measure: Number of patients with other symptomatic thromboembolic events
time frame: Up to 2 years
measure: Treatment satisfaction (patient reported outcomes)
time frame: Up to 2 years
arm group label: Rivaroxaban
description: Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.
arm group label: Standard of care
description: Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine
arm group label: Rivaroxaban
intervention type: Drug
intervention name: Recommended VTE pharmacological treatments according to international guidelines
description: Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.
arm group label: Standard of care
study pop: 
sampling method: 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: 
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country: Algeria
country: Egypt
country: Indonesia
country: Jordan
country: Kazakhstan
country: Kenya
country: Korea, Republic of
country: Kuwait
country: Lebanon
country: Malaysia
country: Mexico
country: Morocco
country: Philippines
country: Qatar
country: Russian Federation
country: Saudi Arabia
country: Singapore
country: Taiwan
country: Turkey
country: Ukraine
country: United Arab Emirates
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Venous Thrombosis
mesh term: Rivaroxaban