<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/NCT03757481</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0005</org_study_id>
    <secondary_id>UF 7548</secondary_id>
    <nct_id>NCT03757481</nct_id>
  </id_info>
  <brief_title>Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE</brief_title>
  <official_title>Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of&#xD;
      previously enrolled patients at least 2 years after the index VTE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HOKUSAI VTE trial was a randomised double blind non inferiority trial that compared the&#xD;
      efficacy and safety of heparin ) (enoxaparin or unfractionated heparin) followed by edoxaban&#xD;
      with heparin (enoxaparin or unfractionated heparin) followed by warfarin (target INR 2-3) in&#xD;
      patients with acute, symptomatic VTE.&#xD;
&#xD;
      Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of&#xD;
      previously enrolled patients at least 2 years after the index VTE.&#xD;
&#xD;
      patients with index DVT will be asked to complete the SF-36 and PembQoL questionnaire to&#xD;
      assess the (venous disease-specific) quality of life.&#xD;
&#xD;
      The Villalta score will be used to assess PTS. The objectively and subjectively obtained&#xD;
      Villalta score- known as the patient reported Villalta -will be compared .&#xD;
&#xD;
      Among patients with with an index PE, the QoL will be assessed bu the validated generic&#xD;
      (SF-36) and DVT at index will be examined for PTS and will be asked to complete all&#xD;
      questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">March 3, 2020</completion_date>
  <primary_completion_date type="Actual">March 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cumulative incidence of PTS in patients with an acute DVT</measure>
    <time_frame>2 years</time_frame>
    <description>PTS is defined by a Villalta index &gt;5 or the presence of venous ulcer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PE related quality of life</measure>
    <time_frame>2 years after the index PE</time_frame>
    <description>questionnaire SF 36</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Post Thrombotic Syndrome</condition>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Chronic Thromboembolic Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>SF-36 questionnaire , PembQoL, Villalta score ,PembQoL</description>
    <arm_group_label>no intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient who participated in the HOKUSAI VTE trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient deprived of liberty&#xD;
&#xD;
          -  patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>isabelle QUERE, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amiens University Hospital</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brest University Hospital</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clermont-Ferrand University Hospital</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dijon University Hospital</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Mans Hospital</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nice University Hospital</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strasbourg University Hospital</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 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>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Postthrombotic Syndrome</mesh_term>
    <mesh_term>Postphlebitic Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03757481
org study id: RECHMPL18_0005
secondary id: UF 7548
nct id: NCT03757481
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of
      previously enrolled patients at least 2 years after the index VTE.
HOKUSAI VTE trial was a randomised double blind non inferiority trial that compared the
      efficacy and safety of heparin ) (enoxaparin or unfractionated heparin) followed by edoxaban
      with heparin (enoxaparin or unfractionated heparin) followed by warfarin (target INR 2-3) in
      patients with acute, symptomatic VTE.

      Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of
      previously enrolled patients at least 2 years after the index VTE.

      patients with index DVT will be asked to complete the SF-36 and PembQoL questionnaire to
      assess the (venous disease-specific) quality of life.

      The Villalta score will be used to assess PTS. The objectively and subjectively obtained
      Villalta score- known as the patient reported Villalta -will be compared .

      Among patients with with an index PE, the QoL will be assessed bu the validated generic
      (SF-36) and DVT at index will be examined for PTS and will be asked to complete all
      questionnaire.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: cumulative incidence of PTS in patients with an acute DVT
time frame: 2 years
description: PTS is defined by a Villalta index >5 or the presence of venous ulcer
measure: PE related quality of life
time frame: 2 years after the index PE
description: questionnaire SF 36
arm group label: no intervention
arm group type: Other
description: patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin
intervention type: Other
intervention name: no intervention
description: SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
arm group label: no intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: isabelle QUERE, PH
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Postthrombotic Syndrome
mesh term: Postphlebitic Syndrome
sharing ipd: No