<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/NCT04479579</url>
  </required_header>
  <id_info>
    <org_study_id>10768</org_study_id>
    <nct_id>NCT04479579</nct_id>
  </id_info>
  <brief_title>Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery</brief_title>
  <official_title>Towards Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Abdominal or Pelvic Major Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, twin-center, cohort study in patients discharged from the hospital&#xD;
      after major abdominal or pelvic cancer surgery for cancer. This study is designed to evaluate&#xD;
      the adherence to extended deep vein thrombosis prophylaxis (DVT) with the direct oral&#xD;
      anticoagulant apixaban on the background of historical data from the investigator's center on&#xD;
      low-molecular-weight heparin (LMWH) substandard adherence in the same setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or&#xD;
      pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more&#xD;
      complicated than orally available prophylaxis, more expensive and has poor adherence.&#xD;
&#xD;
      The patients will be identified in the pre-operative admission or in post-operative orders as&#xD;
      potentially eligible for extended prophylaxis. On the day of discharge a research assistant&#xD;
      or a research nurse will approach the patient, provide information about the study and obtain&#xD;
      written consent if the patient fulfills the eligibility criteria.&#xD;
&#xD;
      Each patient will be asked to take apixaban until postop day 29±1 and will be followed until&#xD;
      postop day 90±3. The total duration of the study from first patient in to last patient out is&#xD;
      expected to take 12 months.&#xD;
&#xD;
      At 1 week after discharge there is a telephone contact to ask about any side effects from&#xD;
      apixaban or bleeding events or signs of thromboembolism and to answer any questions from the&#xD;
      patient.&#xD;
&#xD;
      At postoperative Day +28-30 there is a telephone contact to ask about side effects, bleeding,&#xD;
      signs of venous thromboembolism (VTE), until what date the patient has taken apixaban and&#xD;
      estimate of missed doses using a standardized script. If the patient is still taking it,&#xD;
      instruction will be given to discontinue. Self-reported modified Morisky Medication Adherence&#xD;
      scale with 6 statements will be used At 90 days ±3 days there is the last telephone contact&#xD;
      to ask about bleeding events or signs of VTE. The study is complete for the patient. At the&#xD;
      time of Visit 4 the pharmacy that the patient uses will be contacted to provide dispensing&#xD;
      record for apixaban, in order to verify that the patient filled the prescription.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Actual">November 6, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</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>
    <intervention_model_description>Prospective cohort study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Filled prescription</measure>
    <time_frame>1 week</time_frame>
    <description>Percent of included patients that have filled their prescription for apixaban</description>
  </primary_outcome>
  <primary_outcome>
    <measure>At least 80% adherence</measure>
    <time_frame>30 days</time_frame>
    <description>Percent of patients with filled prescription that have at least 80% adherence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Venous thromboembolism post prophylaxis</measure>
    <time_frame>2 months</time_frame>
    <description>The event rate of venous thromboembolism during the 2 months after planned prophylaxis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of Venous thromboembolism during prophylaxis</measure>
    <time_frame>30 days</time_frame>
    <description>Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Major bleeding during prophylaxis</measure>
    <time_frame>30 days</time_frame>
    <description>Major bleeding during 1st month</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Clinically relevant non-major bleeding during prophylaxis</measure>
    <time_frame>30 days</time_frame>
    <description>Clinically relevant non-major bleeding during 1st month</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Death during prophylaxis</measure>
    <time_frame>30 days</time_frame>
    <description>Death during 1st month</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Neoplasms Malignant</condition>
  <condition>Surgery</condition>
  <condition>Venous Thromboembolism</condition>
  <condition>Prophylaxis</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Apixaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>apixaban for extended prophylaxis against VTE after discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban 2.5 milligram</intervention_name>
    <description>apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day</description>
    <arm_group_label>Apixaban</arm_group_label>
    <other_name>medication adherence assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of at least 18 years of age, discharged after hepato-biliary, colorectal or&#xD;
             gynecology-oncology abdominal/pelvic surgery (laparoscopic or open) for cancer and&#xD;
             considered at increased risk for VTE (e.g. previous history of VTE, residual cancer,&#xD;
             slow mobilization, obesity, comorbidities).&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to take tablets, even if crushed.&#xD;
&#xD;
          -  Active bleeding.&#xD;
&#xD;
          -  Venous thromboembolism diagnosed during the hospitalization.&#xD;
&#xD;
          -  Severe hepatic impairment (Child Pugh class C).&#xD;
&#xD;
          -  Severe renal failure on dialysis or with calculated creatinine clearance &lt;15 mL/min.&#xD;
&#xD;
          -  Platelet count &lt;50·109/L.&#xD;
&#xD;
          -  Concomitant treatment with azole-antimycotics, e.g., ketoconazole, itraconazole,&#xD;
             voriconazole, or posaconazole, and HIV protease inhibitors, e.g., ritonavir.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>male, female, other</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sam Schulman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dr.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thrombosis Service, HHS-General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HHS-Juravinski Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/35362102/</url>
    <description>Publication of the study</description>
  </link>
  <reference>
    <citation>Serrano PE, Parpia S, Valencia M, Simunovic M, Bhandari M, Levine M. Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta-analysis. ANZ J Surg. 2019 Oct;89(10):1217-1223. doi: 10.1111/ans.15290. Epub 2019 Jun 18.</citation>
    <PMID>31210407</PMID>
  </reference>
  <reference>
    <citation>Serrano PE, Parpia S, Linkins LA, Elit L, Simunovic M, Ruo L, Bhandari M, Levine M. Venous Thromboembolic Events Following Major Pelvic and Abdominal Surgeries for Cancer: A Prospective Cohort Study. Ann Surg Oncol. 2018 Oct;25(11):3214-3221. doi: 10.1245/s10434-018-6671-7. Epub 2018 Jul 26.</citation>
    <PMID>30051364</PMID>
  </reference>
  <results_reference>
    <citation>Schulman S, Carlson V, Serrano PE, Sne N, Kahnamoui K, Mithoowani S, Ikesaka R, Gross PL. Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study. J Surg Oncol. 2022 Aug;126(2):386-393. doi: 10.1002/jso.26876. Epub 2022 Apr 1.</citation>
    <PMID>35362102</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Sam Schulman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>apixaban</keyword>
  <keyword>abdominal</keyword>
  <keyword>pelvic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <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>Apixaban</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/NCT04479579
org study id: 10768
nct id: NCT04479579
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a prospective, twin-center, cohort study in patients discharged from the hospital
      after major abdominal or pelvic cancer surgery for cancer. This study is designed to evaluate
      the adherence to extended deep vein thrombosis prophylaxis (DVT) with the direct oral
      anticoagulant apixaban on the background of historical data from the investigator's center on
      low-molecular-weight heparin (LMWH) substandard adherence in the same setting.
All guidelines have embraced the concept of extended DVT prophylaxis after major abdominal or
      pelvic surgery for cancer, but the recommendation is consistently to use LMWH, which is more
      complicated than orally available prophylaxis, more expensive and has poor adherence.

      The patients will be identified in the pre-operative admission or in post-operative orders as
      potentially eligible for extended prophylaxis. On the day of discharge a research assistant
      or a research nurse will approach the patient, provide information about the study and obtain
      written consent if the patient fulfills the eligibility criteria.

      Each patient will be asked to take apixaban until postop day 29±1 and will be followed until
      postop day 90±3. The total duration of the study from first patient in to last patient out is
      expected to take 12 months.

      At 1 week after discharge there is a telephone contact to ask about any side effects from
      apixaban or bleeding events or signs of thromboembolism and to answer any questions from the
      patient.

      At postoperative Day +28-30 there is a telephone contact to ask about side effects, bleeding,
      signs of venous thromboembolism (VTE), until what date the patient has taken apixaban and
      estimate of missed doses using a standardized script. If the patient is still taking it,
      instruction will be given to discontinue. Self-reported modified Morisky Medication Adherence
      scale with 6 statements will be used At 90 days ±3 days there is the last telephone contact
      to ask about bleeding events or signs of VTE. The study is complete for the patient. At the
      time of Visit 4 the pharmacy that the patient uses will be contacted to provide dispensing
      record for apixaban, in order to verify that the patient filled the prescription.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort study
primary purpose: Prevention
masking: None (Open Label)
measure: Filled prescription
time frame: 1 week
description: Percent of included patients that have filled their prescription for apixaban
measure: At least 80% adherence
time frame: 30 days
description: Percent of patients with filled prescription that have at least 80% adherence
measure: Rate of Venous thromboembolism post prophylaxis
time frame: 2 months
description: The event rate of venous thromboembolism during the 2 months after planned prophylaxis
measure: Rate of Venous thromboembolism during prophylaxis
time frame: 30 days
description: Symptomatic, objectively verified deep vein thrombosis of pulmonary embolism during 1st month
measure: Rate of Major bleeding during prophylaxis
time frame: 30 days
description: Major bleeding during 1st month
measure: Rate of Clinically relevant non-major bleeding during prophylaxis
time frame: 30 days
description: Clinically relevant non-major bleeding during 1st month
measure: Rate of Death during prophylaxis
time frame: 30 days
description: Death during 1st month
arm group label: Apixaban
arm group type: Experimental
description: apixaban for extended prophylaxis against VTE after discharge
intervention type: Drug
intervention name: Apixaban 2.5 milligram
description: apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day
arm group label: Apixaban
other name: medication adherence assessment
criteria: 
gender: All
gender based: Yes
gender description: male, female, other
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sam Schulman, MD, PhD
role: Principal Investigator
affiliation: Dr.
facility: 
facility: 
country: Canada
url: https://pubmed.ncbi.nlm.nih.gov/35362102/
description: Publication of the study
citation: Serrano PE, Parpia S, Valencia M, Simunovic M, Bhandari M, Levine M. Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta-analysis. ANZ J Surg. 2019 Oct;89(10):1217-1223. doi: 10.1111/ans.15290. Epub 2019 Jun 18.
PMID: 31210407
citation: Serrano PE, Parpia S, Linkins LA, Elit L, Simunovic M, Ruo L, Bhandari M, Levine M. Venous Thromboembolic Events Following Major Pelvic and Abdominal Surgeries for Cancer: A Prospective Cohort Study. Ann Surg Oncol. 2018 Oct;25(11):3214-3221. doi: 10.1245/s10434-018-6671-7. Epub 2018 Jul 26.
PMID: 30051364
citation: Schulman S, Carlson V, Serrano PE, Sne N, Kahnamoui K, Mithoowani S, Ikesaka R, Gross PL. Adherence to apixaban for extended thromboprophylaxis after major abdominal or pelvic surgery for cancer: A prospective cohort study. J Surg Oncol. 2022 Aug;126(2):386-393. doi: 10.1002/jso.26876. Epub 2022 Apr 1.
PMID: 35362102
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Sam Schulman
investigator title: Professor
mesh term: Neoplasms
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Apixaban
sharing ipd: No