<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/NCT03799822</url>
  </required_header>
  <id_info>
    <org_study_id>OLV 2014/065</org_study_id>
    <nct_id>NCT03799822</nct_id>
  </id_info>
  <brief_title>Oral Anticoagulation in Hemodialysis</brief_title>
  <official_title>Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Onze Lieve Vrouw Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled&#xD;
      Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2&#xD;
      in Hemodialysis Patients.&#xD;
&#xD;
      After termination of this trial, included patients will be asked to participate in the&#xD;
      extension trial by continuing the treament of their respective allocation arm. No new&#xD;
      intervention will be done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled&#xD;
      Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2&#xD;
      in Hemodialysis Patients.&#xD;
&#xD;
      After termination of this trial, included patients will be asked to participate in the&#xD;
      extension trial by continuing the treament of their respective allocation arm. No new&#xD;
      intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding&#xD;
      episodes will be registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>composite of fatal and non-fatal stroke and other cardiovascular events</measure>
    <time_frame>through study completion, on average 3 years</time_frame>
    <description>composite of fatal and non-fatal stroke and other cardiovascular events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>death rate</measure>
    <time_frame>through study completion, on average 3 years</time_frame>
    <description>cause of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety: incidence of life-threatening, major and minor bleeding</measure>
    <time_frame>through study completion, on average 3 years</time_frame>
    <description>incidence of life-threatening, major and minor bleeding</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hemodialysis patients with non valvular atrial fibrillation receiving warfarin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rivaroxaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rivaroxaban + K2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 10 MG Oral Tablet</intervention_name>
    <description>replacement of warfarin by rivaroxaban</description>
    <arm_group_label>rivaroxaban</arm_group_label>
    <arm_group_label>rivaroxaban + K2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MK-7 2000µg thrice weekly</intervention_name>
    <description>dietary supplement of vitamin K2 MK-7 2000µg thrice weekly</description>
    <arm_group_label>rivaroxaban + K2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin K Antagonist - Drug</intervention_name>
    <description>treatment with a vitamin K antagonist</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inclusion in the trial with clinicaltrials.gov identifier NCT02610933&#xD;
&#xD;
          -  signed informed consent for this extension trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rogier Caluwe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OLV Hospital Aalst, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OLV Hospital</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Onze Lieve Vrouw Hospital</investigator_affiliation>
    <investigator_full_name>Rogier Caluwe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>hemodialysis</keyword>
  <keyword>rivaroxaban</keyword>
  <keyword>vitamin K2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Rivaroxaban</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/NCT03799822
org study id: OLV 2014/065
nct id: NCT03799822
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled
      Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2
      in Hemodialysis Patients.

      After termination of this trial, included patients will be asked to participate in the
      extension trial by continuing the treament of their respective allocation arm. No new
      intervention will be done.
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled
      Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2
      in Hemodialysis Patients.

      After termination of this trial, included patients will be asked to participate in the
      extension trial by continuing the treament of their respective allocation arm. No new
      intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding
      episodes will be registered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: composite of fatal and non-fatal stroke and other cardiovascular events
time frame: through study completion, on average 3 years
description: composite of fatal and non-fatal stroke and other cardiovascular events
measure: death rate
time frame: through study completion, on average 3 years
description: cause of death
measure: safety: incidence of life-threatening, major and minor bleeding
time frame: through study completion, on average 3 years
description: incidence of life-threatening, major and minor bleeding
arm group label: Control
arm group type: Active Comparator
description: Hemodialysis patients with non valvular atrial fibrillation receiving warfarin
arm group label: rivaroxaban
arm group type: Experimental
description: Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od
arm group label: rivaroxaban + K2
arm group type: Experimental
description: Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements
intervention type: Drug
intervention name: Rivaroxaban 10 MG Oral Tablet
description: replacement of warfarin by rivaroxaban
arm group label: rivaroxaban
arm group label: rivaroxaban + K2
intervention type: Dietary Supplement
intervention name: MK-7 2000µg thrice weekly
description: dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
arm group label: rivaroxaban + K2
intervention type: Drug
intervention name: Vitamin K Antagonist - Drug
description: treatment with a vitamin K antagonist
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rogier Caluwe, MD
role: Principal Investigator
affiliation: OLV Hospital Aalst, Belgium
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Onze Lieve Vrouw Hospital
investigator full name: Rogier Caluwe
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
mesh term: Vitamin K
mesh term: Rivaroxaban