<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/NCT03276143</url>
  </required_header>
  <id_info>
    <org_study_id>17664</org_study_id>
    <secondary_id>2016-002681-31</secondary_id>
    <nct_id>NCT03276143</nct_id>
  </id_info>
  <brief_title>FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty</brief_title>
  <acronym>FOXTROT</acronym>
  <official_title>A Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Treatment and Observer-blinded to BAY1213790 Doses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or&#xD;
      apixaban, for the prevention of blood clotting and safety in patients undergoing total knee&#xD;
      arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of&#xD;
      BAY1213790. This means that it was known which treatment was given, but it was not known&#xD;
      which dose of BAY1213790 was administered.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">January 2, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded</measure>
    <time_frame>Up to 15 days</time_frame>
    <description>DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of composite endpoint of major and clinically relevant non-major bleeding</measure>
    <time_frame>Up to 15 days</time_frame>
    <description>All suspected events were reviewed and classified by the Central Independent Adjudication Committee.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 157 or objectively confirmed asymptomatic DVT up to Day 15</measure>
    <time_frame>Up to 157 days</time_frame>
    <description>All suspected events were reviewed and classified by the Central Independent Adjudication Committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of composite endpoint of major and clinically relevant non-major bleeding</measure>
    <time_frame>Up to 157 days</time_frame>
    <description>All suspected events were reviewed and classified by the Central Independent Adjudication Committee.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">813</enrollment>
  <condition>Knee Arthroplasty, Total</condition>
  <arm_group>
    <arm_group_label>Enoxaparin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apixaban</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY1213790 0.3 mg/kg (post-surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY1213790 0.6 mg/kg (post-surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY1213790 1.2 mg/kg (post-surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY1213790 1.8 mg/kg (post-surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY1213790 0.3 mg/kg (pre-surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAY1213790 1.8 mg/kg (pre-surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin</intervention_name>
    <description>40 mg enoxaparin administered as subcutaneous injection once daily</description>
    <arm_group_label>Enoxaparin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban</intervention_name>
    <description>2.5 mg apixaban administered as tablet orally twice daily</description>
    <arm_group_label>Apixaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1213790</intervention_name>
    <description>Single dose of BAY1213790 administered as intravenous infusion</description>
    <arm_group_label>BAY1213790 0.3 mg/kg (post-surgery)</arm_group_label>
    <arm_group_label>BAY1213790 0.3 mg/kg (pre-surgery)</arm_group_label>
    <arm_group_label>BAY1213790 0.6 mg/kg (post-surgery)</arm_group_label>
    <arm_group_label>BAY1213790 1.2 mg/kg (post-surgery)</arm_group_label>
    <arm_group_label>BAY1213790 1.8 mg/kg (post-surgery)</arm_group_label>
    <arm_group_label>BAY1213790 1.8 mg/kg (pre-surgery)</arm_group_label>
    <other_name>Osocimab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee&#xD;
             Arthroplasty (TKA)&#xD;
&#xD;
          -  Women of non-childbearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High risk for clinically significant bleeding&#xD;
&#xD;
          -  Prior deep vein thrombosis&#xD;
&#xD;
          -  Body weight above 135 kg&#xD;
&#xD;
          -  Creatinine clearance below 60 ml/min&#xD;
&#xD;
          -  Recent (&lt;6 months) myocardial infarction or ischemic stroke&#xD;
&#xD;
          -  Contraindication listed in the local label of the comparator treatments&#xD;
&#xD;
          -  Requirement for full dose anticoagulation or dual antiplatelet therapy&#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>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMHAT Sveti Georgi</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic Multiprofile Hospital for Active Treatm</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Tsaritsa Joanna-ISUL EAD Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Investigative &amp; Clinical Evaluation Inc.</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 1E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice u sv. Anny</name>
      <address>
        <city>Brno</city>
        <zip>656 91</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Ceske Budejovice, a.s.</name>
      <address>
        <city>Ceske Budejovice</city>
        <zip>370 87</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okresni nemocnice Jindrichuv Hradec</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <zip>377 38</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital Pardubice</name>
      <address>
        <city>Pardubice</city>
        <zip>530 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KAT General Hospital of Athens</name>
      <address>
        <city>Kifisia</city>
        <zip>14561</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konstantopoulio General Hospital of Nea Ionia - Agia Olga</name>
      <address>
        <city>Nea Ionia</city>
        <zip>14233</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Patras</name>
      <address>
        <city>Patras</city>
        <zip>265 04</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papageorgiou General Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>56403</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Corporation</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lady Davis Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clalit Health Services through Rabin Medical Center - Beilinson Campus</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Rehovot</city>
        <zip>7610001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liepaja Regional Hospital</name>
      <address>
        <city>Liepaja</city>
        <zip>LV-3414</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga 2nd City Hospital</name>
      <address>
        <city>Riga</city>
        <zip>LV-1004</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Traumatology and Orthopaedics</name>
      <address>
        <city>Riga</city>
        <zip>LV-1005</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valmiera Hospital</name>
      <address>
        <city>Valmiera</city>
        <zip>LV-4201</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaunas clinical hospital (Laisves ave.)</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-44320</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lithuanian university of Health science</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PI Klaipedos University Hospital</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Vilnius University Hospital</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-04130</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital Santaros Klinikos</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Bialymstoku</name>
      <address>
        <city>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Szpital Zespolony</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny im. Rydygiera</name>
      <address>
        <city>Krakow</city>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ</name>
      <address>
        <city>Lublin</city>
        <zip>20-718</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny UM we Wroclawiu</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cascais</name>
      <address>
        <city>Alcabideche</city>
        <state>Lisboa</state>
        <zip>2755-009</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHS - Hospital Ortopedico Sant Iago do Outao</name>
      <address>
        <city>Setubal</city>
        <state>Setúbal</state>
        <zip>2900-182</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHBV - Hospital Infante D. Pedro</name>
      <address>
        <city>Aveiro</city>
        <zip>3810-501</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHL - Hospital Santo Andre</name>
      <address>
        <city>Leiria</city>
        <zip>2410-197</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ULSAM - Hospital Santa Luzia</name>
      <address>
        <city>Viana do Castelo</city>
        <zip>4901-858</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Scientific Center n.a. acad. G.A. Ilizarov</name>
      <address>
        <city>Kurgan</city>
        <zip>640014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privolzhskiy Federal Medical Research Center</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital #2</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sci-Res. Institute of Traumatology and Orthopaedia</name>
      <address>
        <city>St. Petersburg</city>
        <zip>195427</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital for Emergency Care n.a. N.V.Solovyov</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pretoria Academic Hospital New</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0084</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCT Clinical Research Centre</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Projects Research SA</name>
      <address>
        <city>Worcester</city>
        <state>Western Cape</state>
        <zip>6850</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitària i Universitària de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Hospital Alcorcón</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitària i Universitaria de la Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaén</name>
      <address>
        <city>Jaén</city>
        <zip>23009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cherkasy Reg Clinical Hospital of Cherkasy Reg Council</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Regional Clinical Hospital</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Regional Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>4107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
    <country>Hungary</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>February 28, 2020</last_update_submitted>
  <last_update_submitted_qc>February 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Orthopedic surgery</keyword>
  <keyword>Venous thromboembolism</keyword>
  <keyword>Deep vein thrombosis (DVT)</keyword>
  <keyword>Anticoagulation</keyword>
  <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/NCT03276143
org study id: 17664
secondary id: 2016-002681-31
nct id: NCT03276143
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or
      apixaban, for the prevention of blood clotting and safety in patients undergoing total knee
      arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of
      BAY1213790. This means that it was known which treatment was given, but it was not known
      which dose of BAY1213790 was administered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
time frame: Up to 15 days
description: DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding
time frame: Up to 15 days
description: All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
measure: Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 157 or objectively confirmed asymptomatic DVT up to Day 15
time frame: Up to 157 days
description: All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding
time frame: Up to 157 days
description: All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
arm group label: Enoxaparin
arm group type: Active Comparator
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
arm group label: Apixaban
arm group type: Active Comparator
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
arm group label: BAY1213790 0.3 mg/kg (post-surgery)
arm group type: Experimental
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.
arm group label: BAY1213790 0.6 mg/kg (post-surgery)
arm group type: Experimental
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.
arm group label: BAY1213790 1.2 mg/kg (post-surgery)
arm group type: Experimental
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.
arm group label: BAY1213790 1.8 mg/kg (post-surgery)
arm group type: Experimental
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.
arm group label: BAY1213790 0.3 mg/kg (pre-surgery)
arm group type: Experimental
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.
arm group label: BAY1213790 1.8 mg/kg (pre-surgery)
arm group type: Experimental
description: Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.
intervention type: Drug
intervention name: Enoxaparin
description: 40 mg enoxaparin administered as subcutaneous injection once daily
arm group label: Enoxaparin
intervention type: Drug
intervention name: Apixaban
description: 2.5 mg apixaban administered as tablet orally twice daily
arm group label: Apixaban
intervention type: Drug
intervention name: BAY1213790
description: Single dose of BAY1213790 administered as intravenous infusion
arm group label: BAY1213790 0.3 mg/kg (post-surgery)
arm group label: BAY1213790 0.3 mg/kg (pre-surgery)
arm group label: BAY1213790 0.6 mg/kg (post-surgery)
arm group label: BAY1213790 1.2 mg/kg (post-surgery)
arm group label: BAY1213790 1.8 mg/kg (post-surgery)
arm group label: BAY1213790 1.8 mg/kg (pre-surgery)
other name: Osocimab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Bulgaria
country: Canada
country: Czechia
country: Greece
country: Israel
country: Latvia
country: Lithuania
country: Poland
country: Portugal
country: Russian Federation
country: South Africa
country: Spain
country: Ukraine
country: Germany
country: Hungary
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Enoxaparin
mesh term: Apixaban