<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/NCT02970773</url>
  </required_header>
  <id_info>
    <org_study_id>2013-21</org_study_id>
    <nct_id>NCT02970773</nct_id>
  </id_info>
  <brief_title>Absorption of Rivaroxaban in Patients With Cervical Spinal Cord Injury</brief_title>
  <acronym>rivaroxaban</acronym>
  <official_title>Prospective, Non-randomized, Open-label, Mono-centric, Cohort Study on the Absorption of Oral Rivaroxaban in Patients With a Cervical Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to investigate the pharmacokinetic and -dynamic&#xD;
      properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI)&#xD;
      individuals.&#xD;
&#xD;
      The secondary objective of this study is to determine the steady-state rivaroxaban activity&#xD;
      in cervical SCI individuals under long-term therapy.&#xD;
&#xD;
      Primary Objective In-house patients will be informed concerning the study and informed&#xD;
      consent will be collected.&#xD;
&#xD;
      During the screening day, in- / exclusion criteria will be assessed and a blood samples will&#xD;
      be taken for assessing haematology, clinical chemistry and coagulation parameters.&#xD;
      Furthermore, the evaluation day will be scheduled.&#xD;
&#xD;
      On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will&#xD;
      be introduced into a forearm or lower leg of each participant for the collection of blood at&#xD;
      the specified time points. Skin inspection for subcutaneous bleeding will be performed and&#xD;
      vital signs will be recorded. A blood sample will be taken for assessing haematology,&#xD;
      clinical chemistry and coagulation parameters.&#xD;
&#xD;
      Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer&#xD;
      Schering Pharma, Berlin, Germany).&#xD;
&#xD;
      Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after&#xD;
      and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity&#xD;
      will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12,&#xD;
      24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring&#xD;
      prothrombin time (PT) and activated partial thromboplastin time (aPTT).&#xD;
&#xD;
      Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed&#xD;
      30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.&#xD;
&#xD;
      Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during&#xD;
      their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be&#xD;
      assessed, and the patients will be informed concerning the study and informed consent will be&#xD;
      collected.&#xD;
&#xD;
      Blood samples will be taken for assessing haematology, clinical chemistry and coagulation&#xD;
      parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs&#xD;
      will be performed.&#xD;
&#xD;
      A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and&#xD;
      secondary outcome parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    insufficient recruitment; sponsor-investigator has left the institution&#xD;
  </why_stopped>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">December 7, 2018</completion_date>
  <primary_completion_date type="Actual">December 7, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rivaroxaban plasma level</measure>
    <time_frame>before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>inhibition of factor XII</measure>
    <time_frame>before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prothrombin time</measure>
    <time_frame>before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Thromboembolism</condition>
  <arm_group>
    <arm_group_label>rivaroxaban</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Rivaroxaban Oral Tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban Oral Tablet</intervention_name>
    <description>oral application of Xarelto</description>
    <arm_group_label>rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Motor complete tetraplegia for at least 3 months&#xD;
&#xD;
          -  Age from 18 to 74 years&#xD;
&#xD;
          -  Body mass index (BMI) from 18 to 35kg/m2&#xD;
&#xD;
          -  Informed consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any anti-coagulation therapy (apart from rivaroxaban for second objective)&#xD;
&#xD;
          -  Hypersensitivity or allergy to factor Xa inhibitors&#xD;
&#xD;
          -  Acute bacterial endocarditis&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Clinically relevant active bleeding&#xD;
&#xD;
          -  Gastrointestinal ulcer or tumor&#xD;
&#xD;
          -  Hepatic dysfunction with increased bleeding risk&#xD;
&#xD;
          -  Renal failure / patients undergoing dialysis&#xD;
&#xD;
          -  Pregnancy and breast feeding&#xD;
&#xD;
          -  Gastrectomy, biliopancreatic diversion, resection or re-routing of small intestines&#xD;
&#xD;
          -  Feeding tube&#xD;
&#xD;
          -  Recent blood donation&#xD;
&#xD;
          -  Abnormalities of laboratory values: alanine-aminotransferase (ALAT),&#xD;
             aspartate-aminotransferase (ASAT), gamma-glutamyl transferase (gammaGT), alkalic&#xD;
             phosphatase (AP), bilirubin, amylase, lipase, cystatin C, creatinine, white blood cell&#xD;
             count, haemoglobin, platelet count, prothrombin time, aPTT, fibrinogen, thrombin time,&#xD;
             factors II,V,VII and X&#xD;
&#xD;
          -  Use of therapeutic or recreational drugs influencing plasmatic coagulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Felleiter, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Parapelgic Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swiss Paraplegic Centre Nottwil</name>
      <address>
        <city>Nottwil</city>
        <state>Lucerne</state>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</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>Spinal Cord Injuries</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</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/NCT02970773
org study id: 2013-21
nct id: NCT02970773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary objective of this study is to investigate the pharmacokinetic and -dynamic
      properties of rivaroxaban after oral administration in cervical spinal cord injury (SCI)
      individuals.

      The secondary objective of this study is to determine the steady-state rivaroxaban activity
      in cervical SCI individuals under long-term therapy.

      Primary Objective In-house patients will be informed concerning the study and informed
      consent will be collected.

      During the screening day, in- / exclusion criteria will be assessed and a blood samples will
      be taken for assessing haematology, clinical chemistry and coagulation parameters.
      Furthermore, the evaluation day will be scheduled.

      On the evaluation day, in- / exclusion criteria will be re-assessed. A venous catheter will
      be introduced into a forearm or lower leg of each participant for the collection of blood at
      the specified time points. Skin inspection for subcutaneous bleeding will be performed and
      vital signs will be recorded. A blood sample will be taken for assessing haematology,
      clinical chemistry and coagulation parameters.

      Single administration of oral rivaroxaban in the form of Xarelto® 10mg tablets (Bayer
      Schering Pharma, Berlin, Germany).

      Rivaroxaban concentrations will be determined from plasma samples taken before, 30min after
      and 1, 2, 3, 4, 5, 6, 8, 12, 24 hours after rivaroxaban administration. Rivaroxaban activity
      will be determined from plasma samples taken before, 30min after and 1, 2, 3, 4, 5, 6, 8, 12,
      24 hours after rivaroxaban administration using a factor Xa inhibition test and measuring
      prothrombin time (PT) and activated partial thromboplastin time (aPTT).

      Skin inspection for subcutaneous bleeding and measurements of vital signs will be performed
      30min and 1, 2, 3, 4, 5, 6, 8, 12 and 24 hours after rivaroxaban administration.

      Secondary Objective Patients under long-term rivaroxaban therapy will be recruited during
      their annual check-up visit at the Swiss Paraplegic Centre. In- / exclusion criteria will be
      assessed, and the patients will be informed concerning the study and informed consent will be
      collected.

      Blood samples will be taken for assessing haematology, clinical chemistry and coagulation
      parameters, and skin inspection for subcutaneous bleeding and measurements of vital signs
      will be performed.

      A blood sample (4.3ml citrated venous blood) will be taken for assessing the primary and
      secondary outcome parameters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: rivaroxaban plasma level
time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
measure: inhibition of factor XII
time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
measure: prothrombin time
time frame: before drug administration and 30min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h after drug administration
arm group label: rivaroxaban
arm group type: Other
description: Rivaroxaban Oral Tablet
intervention type: Drug
intervention name: Rivaroxaban Oral Tablet
description: oral application of Xarelto
arm group label: rivaroxaban
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Felleiter, MD PhD
role: Principal Investigator
affiliation: Swiss Parapelgic Centre
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Thromboembolism
mesh term: Wounds and Injuries
mesh term: Rivaroxaban
sharing ipd: No