<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/NCT02238535</url>
  </required_header>
  <id_info>
    <org_study_id>Ventavis_PRPH</org_study_id>
    <nct_id>NCT02238535</nct_id>
  </id_info>
  <brief_title>Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension</brief_title>
  <official_title>Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual&#xD;
      pulmonary hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary hypertension</measure>
    <time_frame>6 months</time_frame>
    <description>The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of deaths</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recurrent pulmonary embolisms</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of venous thromboembolisms</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Residual Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Ventavis + Warfarin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warfarin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ventavis</intervention_name>
    <arm_group_label>Ventavis + Warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin</intervention_name>
    <arm_group_label>Ventavis + Warfarin</arm_group_label>
    <arm_group_label>Warfarin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pulmonary embolism after undergone surgical treatment (intravascular&#xD;
             thrombolysis, catheter thrombus fragmentation)&#xD;
&#xD;
          -  Patients with preserved thromboembolism in the pulmonary circulation system and mean&#xD;
             pressure in the pulmonary artery of more than 25 mm Hg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient did not sign the informed consent.&#xD;
&#xD;
          -  Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg&#xD;
&#xD;
          -  Age above 75 years.&#xD;
&#xD;
          -  Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal&#xD;
             ulcer in acute, hemorrhagic stroke.&#xD;
&#xD;
          -  Severe coronary artery disease (unstable angina, myocardial infarction within the last&#xD;
             6 months).&#xD;
&#xD;
          -  Acute heart failure or CHF IV in NYHA.&#xD;
&#xD;
          -  Severe arrhythmias.&#xD;
&#xD;
          -  Pregnancy, lactation.&#xD;
&#xD;
          -  The presence of severe diseases of other organ systems that may result in death during&#xD;
             the first year after surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yulia Klevanets, MD</last_name>
    <phone>+79139443607</phone>
    <email>klevanetc@yandex.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>State Research Institute of Circulation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yulia Klevanets, MD</last_name>
      <phone>+79139443607</phone>
      <email>klevanetc@yandex.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://meshalkin.ru</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</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>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iloprost</mesh_term>
    <mesh_term>Warfarin</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/NCT02238535
org study id: Ventavis_PRPH
nct id: NCT02238535
lead sponsor: 
has dmc: Yes
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual
      pulmonary hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pulmonary hypertension
time frame: 6 months
description: The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).
measure: Number of deaths
time frame: 6 months
measure: Number of recurrent pulmonary embolisms
time frame: 6 months
measure: Number of venous thromboembolisms
time frame: 6 months
arm group label: Ventavis + Warfarin
arm group type: Active Comparator
description: Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0
arm group label: Warfarin
arm group type: Active Comparator
description: Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)
intervention type: Drug
intervention name: Ventavis
arm group label: Ventavis + Warfarin
intervention type: Drug
intervention name: Warfarin
arm group label: Ventavis + Warfarin
arm group label: Warfarin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yulia Klevanets, MD
phone: +79139443607
email: klevanetc@yandex.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
url: http://meshalkin.ru
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Iloprost
mesh term: Warfarin