<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/NCT03265054</url>
  </required_header>
  <id_info>
    <org_study_id>2017-04</org_study_id>
    <nct_id>NCT03265054</nct_id>
  </id_info>
  <brief_title>Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis</brief_title>
  <acronym>MICROREVE</acronym>
  <official_title>Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE)&#xD;
      affects about 1,200,000 individuals each year in Europe. About 50% of VTE are unprovoked and&#xD;
      20% of these patients will face a recurrent event after the usual three to six-month course&#xD;
      of anticoagulant treatment. To date, most patients are given prolonged anticoagulant&#xD;
      treatment. However, anticoagulant treatment are associated with a major risk of bleeding&#xD;
      (3%/year). Thus an accurate identification of patients with unprovoked VTE with a low risk of&#xD;
      recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding.&#xD;
&#xD;
      Over the past few years, microparticles (MPs) which are small vesicles originating from the&#xD;
      budding of cellular membranes have emerged as important biological entities regulating&#xD;
      hemostasis. MPs expose at their surface procoagulant molecules such as phosphatidylserin and&#xD;
      tissue factor (TF). All data obtained in mouse models support a role of MPs in venous&#xD;
      thrombosis mediated by the TF activation. Moreover, results from clinical studies showed that&#xD;
      TF-MPs was associated with the risk of venous thrombosis. However, the predictive value of&#xD;
      TF-MPs in the recurrence of VTE is unknown. Besides, no study has taken into account the&#xD;
      recent progresses in the understanding of the role of MPs in haemostasis. Indeed, MPs&#xD;
      vectorize molecules which are not only procoagulant but also profibrinolytic. The net result&#xD;
      depends on a balance between both activities (the coagulo-lytic balance). This balance is can&#xD;
      be measured by two complimentary assays on MPs.&#xD;
&#xD;
      We hypothesized that the coagu-lytic balance of MPs is associated with an increased risk of&#xD;
      VTE recurrence after stopping the anticoagulant treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 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>coagu-lytic balance of MPs</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Venous Thromboembolism (VTE)</condition>
  <arm_group>
    <arm_group_label>re-thrombosis</arm_group_label>
    <description>adult patients with a VTE history with at least 3 months of anticoagulant treatment, which suffered from a re-thrombosis within 5 years after stopping the anticoagulant treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no thrombosis recurrence</arm_group_label>
    <description>adult patients with a VTE history with at least 3 months of anticoagulant treatment, without thrombosis recurrence</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Analysis of plasma samples</intervention_name>
    <description>Measuring microparticles (MPs) in Human Plasma Samples</description>
    <arm_group_label>no thrombosis recurrence</arm_group_label>
    <arm_group_label>re-thrombosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        300 adult patients with a VTE history with at least 3 months of anticoagulant treatment.&#xD;
        150 patients which suffered from a re-thrombosis within 5 years after stopping the&#xD;
        anticoagulant treatment, will be age- and sex-matched with 150 without thrombosis&#xD;
        recurrence.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients with a VTE history with at least 3 months of anticoagulant treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Urielle Desalbres</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Romaric Lacroix, MD</last_name>
    <email>romaric.lacroix@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Romaric Lacroix, MD</last_name>
      <email>romaric.lacroix@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</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>Thrombosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Recurrence</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/NCT03265054
org study id: 2017-04
nct id: NCT03265054
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE)
      affects about 1,200,000 individuals each year in Europe. About 50% of VTE are unprovoked and
      20% of these patients will face a recurrent event after the usual three to six-month course
      of anticoagulant treatment. To date, most patients are given prolonged anticoagulant
      treatment. However, anticoagulant treatment are associated with a major risk of bleeding
      (3%/year). Thus an accurate identification of patients with unprovoked VTE with a low risk of
      recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding.

      Over the past few years, microparticles (MPs) which are small vesicles originating from the
      budding of cellular membranes have emerged as important biological entities regulating
      hemostasis. MPs expose at their surface procoagulant molecules such as phosphatidylserin and
      tissue factor (TF). All data obtained in mouse models support a role of MPs in venous
      thrombosis mediated by the TF activation. Moreover, results from clinical studies showed that
      TF-MPs was associated with the risk of venous thrombosis. However, the predictive value of
      TF-MPs in the recurrence of VTE is unknown. Besides, no study has taken into account the
      recent progresses in the understanding of the role of MPs in haemostasis. Indeed, MPs
      vectorize molecules which are not only procoagulant but also profibrinolytic. The net result
      depends on a balance between both activities (the coagulo-lytic balance). This balance is can
      be measured by two complimentary assays on MPs.

      We hypothesized that the coagu-lytic balance of MPs is associated with an increased risk of
      VTE recurrence after stopping the anticoagulant treatment.
observational model: Cohort
time perspective: Retrospective
measure: coagu-lytic balance of MPs
time frame: 12 months
arm group label: re-thrombosis
description: adult patients with a VTE history with at least 3 months of anticoagulant treatment, which suffered from a re-thrombosis within 5 years after stopping the anticoagulant treatment
arm group label: no thrombosis recurrence
description: adult patients with a VTE history with at least 3 months of anticoagulant treatment, without thrombosis recurrence
intervention type: Biological
intervention name: Analysis of plasma samples
description: Measuring microparticles (MPs) in Human Plasma Samples
arm group label: no thrombosis recurrence
arm group label: re-thrombosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urielle Desalbres
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Romaric Lacroix, MD
email: romaric.lacroix@ap-hm.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Venous Thrombosis
mesh term: Recurrence