<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/NCT02979561</url>
  </required_header>
  <id_info>
    <org_study_id>RE-SPIRE study</org_study_id>
    <nct_id>NCT02979561</nct_id>
  </id_info>
  <brief_title>Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy</brief_title>
  <acronym>Re-Spire</acronym>
  <official_title>A Prospective Randomised Controlled Study to Evaluate Outcomes of the Treatment With Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism Undergoing Endovascular Mechanical Fragmentation and Thrombolytic Therapy</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa&#xD;
      or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute&#xD;
      massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic&#xD;
      therapy. [RE-SPIRE study]&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 4</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>recurrent PE</measure>
    <time_frame>6 month</time_frame>
    <description>according to Echocardiogram, scintigraphy of the lungs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>6 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemorrhagic complications</measure>
    <time_frame>6 month</time_frame>
    <description>according to the ISTH criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postembolic residual pulmonary hypertension</measure>
    <time_frame>6 month</time_frame>
    <description>according to scintigraphy of the lungs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrent deep vein thrombosis</measure>
    <time_frame>3 month</time_frame>
    <description>according to ultrasound of the deep veins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrent deep vein thrombosis</measure>
    <time_frame>6 month</time_frame>
    <description>according to ultrasound of the deep veins</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Angiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic Therapy</condition>
  <arm_group>
    <arm_group_label>group of dabigatran</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group of warfarin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran Etexilate</intervention_name>
    <description>All patients in this group continue to receive unfractionated heparin for 5-7 days, and then transferred to the drug Pradaxa dose of 150 mg 2 times a day. Pradaxa administration continued until the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.</description>
    <arm_group_label>group of dabigatran</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin</intervention_name>
    <description>all patients continue to receive unfractionated heparin intravenously and at the same time (from the date of randomization) start warfarin, accompanied by regular measurement of the INR every day or every other day. As soon as INR reaches the range of 2.0 to 3.0, the administration of the unfractionated heparin should be discontinued. Further measurements of INR should be performed once a month during outpatient visits. The patient continues to receive warfarin under the control of the INR till the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.</description>
    <arm_group_label>group of warfarin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged &gt; 18 years&#xD;
&#xD;
          -  Angiographically confirmed acute massive pulmonary embolism with involvement of&#xD;
             Central pulmonary arteries.&#xD;
&#xD;
          -  endovascular mechanical thrombus fragmentation + thrombolytic therapy (using&#xD;
             recombinant tissue activator of plasminogen), performed for treatment of the&#xD;
             above-mentioned pulmonary embolism in less than 48 hours before randomization. The&#xD;
             patient should be randomized no earlier than 24 hours after procedures endovascular&#xD;
             mechanical thrombus fragmentation + thrombolytic therapy&#xD;
&#xD;
          -  Written informed consent signed by patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of hemodynamic instability (i.e. systolic blood pressure &lt;100 mm Hg.St. or&#xD;
             episode of systolic blood pressure fall for ≥40 mm Hg. / or heart rate &gt; 110 lasting&#xD;
             more than 15 min) or need for ventilatory support within 12 hours prior to&#xD;
             randomisation.&#xD;
&#xD;
          -  The indication for oral anticoagulation, associated with others disease.&#xD;
&#xD;
          -  malignant neoplasm of any location&#xD;
&#xD;
          -  Contraindications to warfarin or pradaxa according to Russian Instructions for medical&#xD;
             use of these drugs&#xD;
&#xD;
          -  Indications for concomitant treatment with antiplatelet agents&#xD;
&#xD;
          -  Any stroke within 6 months before randomization&#xD;
&#xD;
          -  Intracranial hemorrhage in anamnesis&#xD;
&#xD;
          -  Active bleeding, bleeding diathesis.&#xD;
&#xD;
          -  Clinically significant bleeding within the last 30 days.&#xD;
&#xD;
          -  Trauma or extensive surgery within 1 month before randomization or surgery planned in&#xD;
             the next 6 months after randomization.&#xD;
&#xD;
          -  Intracranial pathology: tumor, arteriovenous fistula or aneurysm.&#xD;
&#xD;
          -  Gastrointestinal bleeding in the previous 3 months.&#xD;
&#xD;
          -  Gastric ulcer or duodenal ulcer with clinical manifestations or endoscopically&#xD;
             identified acute ulcer without signs of scarring during previous 30 days.&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure&gt; 180 mm Hg. and / or diastolic&#xD;
             blood pressure&gt; 100 mm.hg in patients receiving antihypertensive drugs).&#xD;
&#xD;
          -  Pregnancy, lactation.&#xD;
&#xD;
          -  Life expectancy &lt;6 months.&#xD;
&#xD;
          -  Clinically significant liver disease.&#xD;
&#xD;
          -  Creatinine clearance (estimated by Cockcroft-Gault) &lt;30 ml / min.&#xD;
&#xD;
          -  hemoglobin level &lt;90 g/l), thrombocytopenia &lt;100x10^9 / L.&#xD;
&#xD;
          -  Patients who, in the opinion of the researcher, are not suitable for inclusion in the&#xD;
             study, for example, due to the low likelihood of doctor's recommendations following.&#xD;
&#xD;
          -  Long-term use of NSAIDs&#xD;
&#xD;
          -  Current participation in another clinical study.&#xD;
&#xD;
          -  Allergic to contrast substance or radioisotope drugs used in procedures to assess&#xD;
             endpoints of the study, which according to researchers, may be a contraindication to&#xD;
             the implementation of these research methods.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andrey Karpenko, MD\PhD</last_name>
    <email>a_karpenko@meshalkin.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexey Cheban, MD</last_name>
    <email>cheban_a@meshalkin.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexey Cheban, MD</last_name>
      <email>cheban_a@meshalkin.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dabigatran etexilate</keyword>
  <keyword>Recurrence of DVT</keyword>
  <keyword>Pulmonary Embolism</keyword>
  <keyword>Warfarin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
  </intervention_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/NCT02979561
org study id: RE-SPIRE study
nct id: NCT02979561
lead sponsor: 
has dmc: No
A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa
      or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute
      massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic
      therapy. [RE-SPIRE study]
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recurrent PE
time frame: 6 month
description: according to Echocardiogram, scintigraphy of the lungs
measure: death
time frame: 6 month
measure: hemorrhagic complications
time frame: 6 month
description: according to the ISTH criteria
measure: postembolic residual pulmonary hypertension
time frame: 6 month
description: according to scintigraphy of the lungs
measure: recurrent deep vein thrombosis
time frame: 3 month
description: according to ultrasound of the deep veins
measure: recurrent deep vein thrombosis
time frame: 6 month
description: according to ultrasound of the deep veins
arm group label: group of dabigatran
arm group type: Experimental
arm group label: group of warfarin
arm group type: Active Comparator
intervention type: Drug
intervention name: Dabigatran Etexilate
description: All patients in this group continue to receive unfractionated heparin for 5-7 days, and then transferred to the drug Pradaxa dose of 150 mg 2 times a day. Pradaxa administration continued until the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.
arm group label: group of dabigatran
intervention type: Drug
intervention name: Warfarin
description: all patients continue to receive unfractionated heparin intravenously and at the same time (from the date of randomization) start warfarin, accompanied by regular measurement of the INR every day or every other day. As soon as INR reaches the range of 2.0 to 3.0, the administration of the unfractionated heparin should be discontinued. Further measurements of INR should be performed once a month during outpatient visits. The patient continues to receive warfarin under the control of the INR till the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.
arm group label: group of warfarin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrey Karpenko, MD\PhD
email: a_karpenko@meshalkin.ru
last name: Alexey Cheban, MD
email: cheban_a@meshalkin.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Warfarin
mesh term: Dabigatran
sharing ipd: No