<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/NCT04444804</url>
  </required_header>
  <id_info>
    <org_study_id>21456</org_study_id>
    <nct_id>NCT04444804</nct_id>
  </id_info>
  <brief_title>Study to Compare the Effectiveness of Rivaroxaban (Xarelto) Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism in Routine Clinical Practice in Germany</brief_title>
  <official_title>Real-world Comparative Effectiveness of Rivaroxaban Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism (RECENT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>
      Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus&#xD;
      low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary&#xD;
      prevention of venous thromboembolism by evaluating routine clinical practice data from&#xD;
      research database in Germany. VTE is defined by a blood clot in the leg or lower extremity&#xD;
      (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE&#xD;
      traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH),&#xD;
      followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly&#xD;
      phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative&#xD;
      VTE treatment and has been approved for both the acute and maintenance phase of VTE&#xD;
      treatment. The study will enroll adult male or female patients who are newly diagnosed with&#xD;
      VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers&#xD;
      are especially interested whether patients experience under treatment any VTE events or fatal&#xD;
      bleedings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</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>Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon</measure>
    <time_frame>Retrospective data from January 2013 to December 2018</time_frame>
    <description>A recurrent VTE event will be defined as a hospitalization with a primary hospital discharge diagnoses for VTE for which the admission date was &gt;14 days after the index date.&#xD;
Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk of fatal bleeding in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon</measure>
    <time_frame>Retrospective data from January 2013 to December 2018</time_frame>
    <description>Cases of fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.&#xD;
Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">22153</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-molecular-weight heparin (LMWH) and Phenprocoumon</arm_group_label>
    <description>The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY 59-7939)</intervention_name>
    <description>Dosage at the discretion of the treating physician</description>
    <arm_group_label>Rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LMWH and Phenprocoumon</intervention_name>
    <description>Dosage at the discretion of the treating physician</description>
    <arm_group_label>Low-molecular-weight heparin (LMWH) and Phenprocoumon</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The source population of this study will include all insured members of more than 60 German&#xD;
        statutory health insurances (SHIs) contributing data to the InGef database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one new diagnosis of VTE during the inclusion period:&#xD;
&#xD;
          -  Ambulatory diagnosis, coded as verified,&#xD;
&#xD;
          -  Primary hospital discharge diagnosis.&#xD;
&#xD;
          -  Secondary hospital discharge diagnosis The quarter of the first VTE diagnosis in the&#xD;
             inclusion period will be defined as the index quarter. For hospital diagnoses, the&#xD;
             date of admission will be used to define the index quarter.&#xD;
&#xD;
          -  The 12 months prior to the index date will define the baseline period for all included&#xD;
             patients. Patients treated with anticoagulation regimens other than defined above&#xD;
             (e.g. other DOACs) will not be included in the study. All patients will have to&#xD;
             fulfill the additional inclusion criteria:&#xD;
&#xD;
          -  Continuous enrolment in the baseline period&#xD;
&#xD;
          -  ≥ 18 years of age at index date&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A verified ambulatory or primary/ secondary hospital discharge diagnosis of VTE in the&#xD;
             baseline period;&#xD;
&#xD;
          -  A verified ambulatory or primary/ secondary hospital discharge diagnosis of atrial&#xD;
             fibrillation in the baseline period; Individuals with documented cardiac valve surgery&#xD;
             in the baseline period;&#xD;
&#xD;
          -  A verified ambulatory or primary/ secondary hospital discharge diagnosis indicating&#xD;
             pregnancy in the baseline period;&#xD;
&#xD;
          -  A prescription of any anticoagulation treatment (heparins; vitamin-K antagonists;&#xD;
             rivaroxaban; other DOACs) in the baseline period;&#xD;
&#xD;
          -  A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage&#xD;
             kidney disease or a claim for dialysis in the baseline period;&#xD;
&#xD;
          -  A prescription of contraindicated drug for rivaroxaban due to drug interactions (i.e.&#xD;
             azole antifungals and HIV protease inhibitors) in the 60 days before or on the index&#xD;
             date.&#xD;
&#xD;
          -  Patients assigned to rivaroxaban exposure groups who were initially treated with a&#xD;
             dose strength other than 15 mg or 20 mg per tablet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Multiple facilities</name>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</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>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Phenprocoumon</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</ipd_description>
  </patient_data>
  <!-- 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/NCT04444804
org study id: 21456
nct id: NCT04444804
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus
      low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary
      prevention of venous thromboembolism by evaluating routine clinical practice data from
      research database in Germany. VTE is defined by a blood clot in the leg or lower extremity
      (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE
      traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH),
      followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly
      phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative
      VTE treatment and has been approved for both the acute and maintenance phase of VTE
      treatment. The study will enroll adult male or female patients who are newly diagnosed with
      VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers
      are especially interested whether patients experience under treatment any VTE events or fatal
      bleedings.
observational model: Cohort
time perspective: Retrospective
measure: Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
time frame: Retrospective data from January 2013 to December 2018
description: A recurrent VTE event will be defined as a hospitalization with a primary hospital discharge diagnoses for VTE for which the admission date was >14 days after the index date.
Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.
measure: Risk of fatal bleeding in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon
time frame: Retrospective data from January 2013 to December 2018
description: Cases of fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.
Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.
arm group label: Rivaroxaban
description: The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.
arm group label: Low-molecular-weight heparin (LMWH) and Phenprocoumon
description: The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY 59-7939)
description: Dosage at the discretion of the treating physician
arm group label: Rivaroxaban
intervention type: Drug
intervention name: LMWH and Phenprocoumon
description: Dosage at the discretion of the treating physician
arm group label: Low-molecular-weight heparin (LMWH) and Phenprocoumon
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Rivaroxaban
mesh term: Phenprocoumon
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.