<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/NCT03282643</url>
  </required_header>
  <id_info>
    <org_study_id>Rivaroxaban vs heparin</org_study_id>
    <nct_id>NCT03282643</nct_id>
  </id_info>
  <brief_title>Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients</brief_title>
  <official_title>Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous&#xD;
      low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among&#xD;
      cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2016</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>Phase 1/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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of deep venous thrombosis</measure>
    <time_frame>4 weeks</time_frame>
    <description>the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban 10mg daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>orally, 10 mg once daily for day1 and day 2 after femoral venepuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rivaroxaban 20mg daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-molecular-weight heparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 10 MG</intervention_name>
    <description>Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture</description>
    <arm_group_label>Rivaroxaban 10mg daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 20 MG</intervention_name>
    <description>Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture</description>
    <arm_group_label>Rivaroxaban 20mg daily</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low-molecular-weight heparin</intervention_name>
    <description>0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)</description>
    <arm_group_label>Low-molecular-weight heparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 85&#xD;
&#xD;
          -  Histologically or cytologically confirmed advanced or metastatic solid tumors&#xD;
&#xD;
          -  Patients will be received femoral venepuncture for apheresis by cell separator, which&#xD;
             is the necessary process to perform following adoptive cell immunotherapy.&#xD;
&#xD;
          -  Estimated life expectancy &gt; 3 months&#xD;
&#xD;
          -  Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is&#xD;
             acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR &lt;1.5&#xD;
             (unless patient is receiving warfarin in which case PT-INR must be &lt;3), PTT &lt;1.5X ULN&#xD;
&#xD;
          -  Adequate renal and hepatic function, with serum creatinine &lt; 1.5 mg/dL, bilirubin &lt;&#xD;
             1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT&#xD;
             and AST ≤ 2.5 x upper limit of normal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known conditions associated with high risk of bleeding, known history of hemorrhagic&#xD;
             diathesis&#xD;
&#xD;
          -  Platelet count &lt; 50 000 G/L&#xD;
&#xD;
          -  Active bleeding&#xD;
&#xD;
          -  Patients with a history of autoimmune disease, such as but not restricted to,&#xD;
             inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,&#xD;
             scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo&#xD;
             are permitted.&#xD;
&#xD;
          -  Patients with obstructive jaundice&#xD;
&#xD;
          -  Patients with Spleen hyperfunction&#xD;
&#xD;
          -  Presence of an active acute or chronic infection including: a urinary tract infection,&#xD;
             HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are&#xD;
             excluded based on immuno-suppression, which may render them unable to respond to the&#xD;
             vaccine; patients with chronic hepatitis are excluded because of concern that&#xD;
             hepatitis could be exacerbated by the injections.&#xD;
&#xD;
          -  Pregnant or breast-feeding women，or lack of effective contraceptive treatment for&#xD;
             women of childbearing age.;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Jun Ren MD, PhD</investigator_full_name>
    <investigator_title>Dean &amp; Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
    <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/NCT03282643
org study id: Rivaroxaban vs heparin
nct id: NCT03282643
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous
      low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among
      cancer patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence rate of deep venous thrombosis
time frame: 4 weeks
description: the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 4 weeks
description: Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0
arm group label: Rivaroxaban 10mg daily
arm group type: Experimental
description: orally, 10 mg once daily for day1 and day 2 after femoral venepuncture
arm group label: Rivaroxaban 20mg daily
arm group type: Experimental
description: orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture
arm group label: Low-molecular-weight heparin
arm group type: Active Comparator
description: subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)
intervention type: Drug
intervention name: Rivaroxaban 10 MG
description: Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture
arm group label: Rivaroxaban 10mg daily
intervention type: Drug
intervention name: Rivaroxaban 20 MG
description: Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture
arm group label: Rivaroxaban 20mg daily
intervention type: Drug
intervention name: Low-molecular-weight heparin
description: 0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)
arm group label: Low-molecular-weight heparin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jun Ren MD, PhD
investigator title: Dean & Director
mesh term: Thrombosis
mesh term: Heparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin
mesh term: Rivaroxaban
sharing ipd: No