<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/NCT01710267</url>
  </required_header>
  <id_info>
    <org_study_id>12041</org_study_id>
    <nct_id>NCT01710267</nct_id>
  </id_info>
  <brief_title>Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)</brief_title>
  <acronym>RivaMoS2</acronym>
  <official_title>Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Foundation, Division of Hematology, Luzerner Kantonsspital, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Luzerner Kantonsspital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied&#xD;
      for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA&#xD;
      is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for&#xD;
      prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.&#xD;
&#xD;
      This is an explorative laboratory study to evaluate the intra-individual variability of RXA&#xD;
      conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied&#xD;
      for prophylaxis of venous thromboembolism (VTE) after major orthopedic surgery of the lower&#xD;
      limbs such as hip and knee replacement surgery. Additionally, RXA is approved by Swissmedic&#xD;
      to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of&#xD;
      cerebrovascular events in non-valvular atrial fibrillation.&#xD;
&#xD;
      Monitoring of RXA concentration (conc.) is generally not required because of its stable&#xD;
      pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency.&#xD;
      However, there are several clinical situations, in which it may be desirable to measure the&#xD;
      RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels of&#xD;
      median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once daily&#xD;
      doses of 20 mg RXA.&#xD;
&#xD;
      This is an explorative laboratory study to evaluate the intra-individual variability of RXA&#xD;
      conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the effect of RXA on trough and peak RXA conc. values in time</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the effect of RXA on coagulation assays in time</measure>
    <time_frame>14 days</time_frame>
    <description>coagulation assays such as PT, PTT, individual coagulation factors, PiCT, ROTEM, multiplate</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Observation group</arm_group_label>
    <description>This group includes all volunteers of this observation study.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples for coagulation assays&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy male volunteers aged 18-65 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male, aged 18-65 years&#xD;
&#xD;
          -  No known comorbidity or disease&#xD;
&#xD;
          -  No known galactose intolerance, lactase deficiency or glucose galactose malabsorption&#xD;
&#xD;
          -  Taking no other medicaments&#xD;
&#xD;
          -  No history for disorders regarding hemostasis&#xD;
&#xD;
          -  Initial screening laboratory test showing normal values for liver/pancreas function&#xD;
             (ALAT,ASAT,gGT, alkalic phosphatase, bilirubin, amylase, lipase), kidney function&#xD;
             (creatinine), hematogram (white blood cell count, hemoglobin, platelet count), and&#xD;
             coagulation parameters (&quot;Gerinnungsstatus&quot; with PT, aPTT, fibrinogen, thrombin time)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter A Wuillemin, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Luzerner Kantonsspital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Luzerner Kantonsspital</name>
      <address>
        <city>Luzern</city>
        <state>LU</state>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://www.luks.ch/standorte/luzern/kliniken/medizin/haematologie.html</url>
    <description>Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Luzerner Kantonsspital</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD</investigator_full_name>
    <investigator_title>Chief, Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland</investigator_title>
  </responsible_party>
  <!-- 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/NCT01710267
org study id: 12041
nct id: NCT01710267
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied
      for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA
      is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for
      prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.

      This is an explorative laboratory study to evaluate the intra-individual variability of RXA
      conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied
      for prophylaxis of venous thromboembolism (VTE) after major orthopedic surgery of the lower
      limbs such as hip and knee replacement surgery. Additionally, RXA is approved by Swissmedic
      to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of
      cerebrovascular events in non-valvular atrial fibrillation.

      Monitoring of RXA concentration (conc.) is generally not required because of its stable
      pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency.
      However, there are several clinical situations, in which it may be desirable to measure the
      RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels of
      median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once daily
      doses of 20 mg RXA.

      This is an explorative laboratory study to evaluate the intra-individual variability of RXA
      conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the effect of RXA on trough and peak RXA conc. values in time
time frame: 14 days
measure: Evaluation of the effect of RXA on coagulation assays in time
time frame: 14 days
description: coagulation assays such as PT, PTT, individual coagulation factors, PiCT, ROTEM, multiplate
arm group label: Observation group
description: This group includes all volunteers of this observation study.
Plasma samples for coagulation assays
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Walter A Wuillemin, MD PhD
role: Principal Investigator
affiliation: Luzerner Kantonsspital
facility: 
country: Switzerland
url: https://www.luks.ch/standorte/luzern/kliniken/medizin/haematologie.html
description: Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Luzerner Kantonsspital
investigator full name: Prof. Dr. Dr. med. Walter A. Wuillemin, MD, PhD
investigator title: Chief, Division of Hematology and Central Hematology Laboratory, Luzerner Kantonsspital, Switzerland