<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/NCT04504318</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-49355</org_study_id>
    <nct_id>NCT04504318</nct_id>
  </id_info>
  <brief_title>Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT</brief_title>
  <official_title>A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford 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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the&#xD;
      efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level&#xD;
      factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population&#xD;
      at particular risk is the growing number of patients who undergo autologous breast&#xD;
      reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more&#xD;
      efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has&#xD;
      the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population&#xD;
      of patients undergoing plastic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apixaban vs. Enoxaparin - Bleeding event</measure>
    <time_frame>90-day events</time_frame>
    <description>To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event</measure>
    <time_frame>90-day events</time_frame>
    <description>To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Apixaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enoxaparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban 2.5 MG Oral Tablet</intervention_name>
    <description>Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.</description>
    <arm_group_label>Apixaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin 40Mg/0.4mL Prefilled Syringe</intervention_name>
    <description>Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.</description>
    <arm_group_label>Enoxaparin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (&gt;18 years) women&#xD;
&#xD;
          -  Scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with&#xD;
             free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous&#xD;
             [TRAM] and/or deep inferior epigastric artery perforator [DIEP]) flap)&#xD;
&#xD;
          -  Caprini score of 6 or greater.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to the use of apixaban or enoxaparin&#xD;
&#xD;
          -  Active bleeding&#xD;
&#xD;
          -  History of bleeding disorder&#xD;
&#xD;
          -  History of coagulopathy&#xD;
&#xD;
          -  History of heparin-induced thrombocytopenia&#xD;
&#xD;
          -  History of liver disease&#xD;
&#xD;
          -  History of renal disease (creatinine clearance &lt;30 mL/min; serum creatinine &gt;1.6&#xD;
             mg/dL)&#xD;
&#xD;
          -  Major neurosurgical intervention (brain/spine) within the past 90 days&#xD;
&#xD;
          -  Ophthalmologic procedure within the past 90 days&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  History of alcohol and/or substance abuse&#xD;
&#xD;
          -  Need for therapeutic anticoagulation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arash Momeni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arash Momeni, MD</last_name>
    <phone>650-723-6189</phone>
    <email>smeyer27@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arash Momeni, MD</last_name>
      <phone>650-723-6189</phone>
      <email>smeyer27@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Arash Momeni</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery (Plastic Surgery)</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>Enoxaparin</mesh_term>
    <mesh_term>Apixaban</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04504318
org study id: IRB-49355
nct id: NCT04504318
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the
      efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level
      factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population
      at particular risk is the growing number of patients who undergo autologous breast
      reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more
      efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has
      the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population
      of patients undergoing plastic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Apixaban vs. Enoxaparin - Bleeding event
time frame: 90-day events
description: To examine the rate of bleeding events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
measure: Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event
time frame: 90-day events
description: To examine the rate of VTE events in patients receiving oral apixaban versus subcutaneous enoxaparin following microsurgical breast reconstruction
arm group label: Apixaban
arm group type: Experimental
description: Patients assigned to this group will receive Apixaban 2.5 mg PO BID starting 12 hours after completing skin closure.
arm group label: Enoxaparin
arm group type: Active Comparator
description: Patients assigned to this group will receive Enoxaparin 40 mg SC QD starting 12 hours after completing skin closure.
intervention type: Drug
intervention name: Apixaban 2.5 MG Oral Tablet
description: Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.
arm group label: Apixaban
intervention type: Drug
intervention name: Enoxaparin 40Mg/0.4mL Prefilled Syringe
description: Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.
arm group label: Enoxaparin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Arash Momeni, MD
role: Principal Investigator
affiliation: Stanford University
last name: Arash Momeni, MD
phone: 650-723-6189
email: smeyer27@stanford.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Arash Momeni
investigator title: Assistant Professor of Surgery (Plastic Surgery)
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Enoxaparin
mesh term: Apixaban