<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/NCT01720108</url>
  </required_header>
  <id_info>
    <org_study_id>EPCATII.001</org_study_id>
    <nct_id>NCT01720108</nct_id>
  </id_info>
  <brief_title>Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty</brief_title>
  <acronym>EPCAT II</acronym>
  <official_title>Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Anderson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators want to look at whether using aspirin instead of rivaroxaban&#xD;
      (after initial treatment with rivaroxaban) works as well at preventing blood clots while also&#xD;
      reducing risk of bleeding and is more cost effective in patients who have either a total hip&#xD;
      replacement or total knee replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2013</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>symptomatic venous thromboembolism</measure>
    <time_frame>up to 4 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>major or clinically relevant non-major bleeding</measure>
    <time_frame>up to 4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke</measure>
    <time_frame>up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound infection</measure>
    <time_frame>up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness</measure>
    <time_frame>up to 4 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3426</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>rivaroxaban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rivaroxaban and ASA</intervention_name>
    <arm_group_label>ASA</arm_group_label>
    <arm_group_label>rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. All patients undergoing elective total hip or knee arthroplasty at the participating&#xD;
        institutions will be potentially eligible for this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hip or lower limb fracture in the previous three months&#xD;
&#xD;
          2. Metastatic cancer&#xD;
&#xD;
          3. Life expectancy less than 6 months&#xD;
&#xD;
          4. History of major bleeding that in the judgment of the investigator precludes use of&#xD;
             anticoagulant prophylaxis&#xD;
&#xD;
          5. History of aspirin allergy, active peptic ulcer disease or gastritis that in judgment&#xD;
             of investigator precludes use of aspirin&#xD;
&#xD;
          6. History of significant hepatic disease or any other condition that in the judgement of&#xD;
             the investigator precludes the use of rivaroxaban&#xD;
&#xD;
          7. Creatinine clearance less than 30 ml per minute&#xD;
&#xD;
          8. Platelet count less than 100 x 109 /L&#xD;
&#xD;
          9. Need for long-term anticoagulation due to a preexisting co-morbid condition or due to&#xD;
             the development of venous thromboembolism following surgery but prior to randomization&#xD;
&#xD;
         10. Did not or will not receive rivaroxaban post-operatively for VTE prophylaxis&#xD;
&#xD;
         11. Bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty&#xD;
&#xD;
         12. Major surgical procedure within the previous three months&#xD;
&#xD;
         13. Requirement for major surgery post arthroplasty within 90 day period&#xD;
&#xD;
         14. Chronic daily aspirin use with dose greater than 100 mg a day&#xD;
&#xD;
         15. Women of child bearing potential who are not abstinent or do not use appropriate&#xD;
             contraception throughout the study drug period&#xD;
&#xD;
         16. Geographical inaccessibility for follow-up&#xD;
&#xD;
         17. Unwilling or unable to give consent&#xD;
&#xD;
         18. Previous participation in the study&#xD;
&#xD;
         19. Concomitant use with drugs that are strong inhibitors or inducers of both P-gp and&#xD;
             CYP3A4&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R Anderson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Capital Health</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>David Anderson</investigator_full_name>
    <investigator_title>Head, Department of Medicine, CDHA</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</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/NCT01720108
org study id: EPCATII.001
nct id: NCT01720108
lead sponsor: 
collaborator: 
has dmc: Yes
In this study the investigators want to look at whether using aspirin instead of rivaroxaban
      (after initial treatment with rivaroxaban) works as well at preventing blood clots while also
      reducing risk of bleeding and is more cost effective in patients who have either a total hip
      replacement or total knee replacement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: symptomatic venous thromboembolism
time frame: up to 4 years
measure: major or clinically relevant non-major bleeding
time frame: up to 4 years
measure: survival
time frame: up to 4 years
measure: myocardial infarction
time frame: up to 4 years
measure: stroke
time frame: up to 4 years
measure: wound infection
time frame: up to 4 years
measure: cost-effectiveness
time frame: up to 4 years
arm group label: rivaroxaban
arm group type: Active Comparator
description: rivaroxaban 10mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
arm group label: ASA
arm group type: Experimental
description: ASA 81mg x 9 days for total knee arthroplasty patients; x 30 days for total hip athroplasty patients
intervention type: Drug
intervention name: rivaroxaban and ASA
arm group label: ASA
arm group label: rivaroxaban
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David R Anderson, MD
role: Principal Investigator
affiliation: Nova Scotia Health Authority
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: David Anderson
investigator title: Head, Department of Medicine, CDHA
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Rivaroxaban
sharing ipd: No