<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/NCT01729871</url>
  </required_header>
  <id_info>
    <org_study_id>CR100732</org_study_id>
    <secondary_id>RIVAROXAFL3002</secondary_id>
    <secondary_id>2012-001484-79</secondary_id>
    <nct_id>NCT01729871</nct_id>
  </id_info>
  <brief_title>A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy</brief_title>
  <acronym>VENTURE-AF</acronym>
  <official_title>A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Janssen Scientific Affairs, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this exploratory study is to evaluate the safety of rivaroxaban and&#xD;
      uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial&#xD;
      fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major&#xD;
      bleeding events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (participants are assigned to intervention groups by chance), open-label&#xD;
      (both physicians and participants know the identity of the assigned treatment),&#xD;
      active-controlled, multi-center safety study of rivaroxaban or VKA before and after a&#xD;
      catheter ablation procedure. This study requires collaboration with medical institutions that&#xD;
      provide access to electrophysiologists who normally perform the catheter ablation procedure.&#xD;
      In this study, NVAF is to be defined as the presence of AF in a person who does not have a&#xD;
      prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or&#xD;
      valvuloplasty are permitted) and who does not have hemodynamically significant mitral valve&#xD;
      stenosis. Approximately 250 eligible participants, age 18 years or older, with a history of&#xD;
      paroxysmal, persistent, or long standing persistent NVAF who are scheduled to undergo an&#xD;
      elective catheter ablation procedure will be randomized in a 1:1 ratio to receive either&#xD;
      rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal or VKA&#xD;
      (adjusted to achieve a recommended International Normalized Ratio of 2.0 to 3.0).&#xD;
&#xD;
      The study will consist of a screening period, a pre-procedure period, procedure period and&#xD;
      post-procedure period. The screening period will begin up to 2 weeks prior to randomization.&#xD;
      Participants will be randomized at the beginning of the pre-procedure period. During this&#xD;
      period, participants will be recommended to receive their assigned treatment for at least 4&#xD;
      weeks (maximum of 5 weeks) before the catheter ablation procedure. For participants with the&#xD;
      sufficient anticoagulation, documented for the 3 weeks prior to randomization, and for&#xD;
      participants with a transesophageal echocardiogram (TEE) or intracardiac echocardiography&#xD;
      (ICE), the length of the pre-procedure period may be reduced down to 1-7 days and must&#xD;
      include any transition from the previous anticoagulation therapy to randomized study drug.&#xD;
&#xD;
      After the catheter ablation procedure, participants will receive their post-procedure dose of&#xD;
      study drug through a minimum of 30 + - 5 days. In addition to scheduled visits and telephone&#xD;
      calls the study may also include additional phone calls and visits by the participant to the&#xD;
      site when dose adjustment is required for usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Incidence of Post-Procedure Major Bleeding Events</measure>
    <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
    <description>Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death</measure>
    <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
    <description>The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Myocardial Infarction (MI)</measure>
    <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
    <description>The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (&gt;) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ischemic Stroke</measure>
    <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
    <description>Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism</measure>
    <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
    <description>The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vascular Death</measure>
    <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
    <description>Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">253</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>rivaroxaban</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin K antagonist (VKA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rivaroxaban</intervention_name>
    <description>rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal</description>
    <arm_group_label>rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>uninterrupted vitamin K antagonist (VKA)</intervention_name>
    <description>dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0</description>
    <arm_group_label>vitamin K antagonist (VKA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation&#xD;
             (NVAF);&#xD;
&#xD;
          -  Have a documented history of paroxysmal (lasting &lt;1 week) or persistent (lasting &gt;1&#xD;
             week and &lt;1 year or requiring pharmacological or electrical cardioversion), or long&#xD;
             standing persistent (&gt;=1 year) NVAF;&#xD;
&#xD;
          -  Be suitable for anticoagulant therapy and catheter ablation as per the judgment of the&#xD;
             investigator;&#xD;
&#xD;
          -  Women must be postmenopausal before entry or practicing a highly effective method of&#xD;
             birth control when heterosexually active;&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test at&#xD;
             screening;&#xD;
&#xD;
          -  Be willing and able to adhere to the prohibitions and restrictions specified in the&#xD;
             study protocol;&#xD;
&#xD;
          -  Have a life expectancy of at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive&#xD;
             status epilepticus within 6 months of the screening visit;&#xD;
&#xD;
          -  Has a history of a major bleeding or thromboembolic event within the 12 months&#xD;
             immediately preceding the catheter ablation procedure;&#xD;
&#xD;
          -  Has had major surgery (requiring general anesthesia), within 6 months before screening&#xD;
             or planned surgery during the time the subject is expected to participate in the&#xD;
             study;&#xD;
&#xD;
          -  Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or&#xD;
             noncardiac cause of NVAF;&#xD;
&#xD;
          -  Has any condition that, in the opinion of the investigator, would make participation&#xD;
             not be in the best interest (eg, compromise the well-being) of the participant or that&#xD;
             could prevent, limit, or confound the protocol-specified assessments&#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>Janssen Scientific Affairs, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Scientific Affairs, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Louis Park</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brest Cedex 2</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pessac Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toulouse Cedex 9 N/A</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bad Krozingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bad Nauheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mönchengladbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Neuwied</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>October 9, 2015</results_first_submitted>
  <results_first_submitted_qc>October 9, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 10, 2015</results_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Irregular heart beat</keyword>
  <keyword>Catheter Ablation</keyword>
  <keyword>Rivaroxaban</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin K</mesh_term>
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were randomized at 37 sites in 5 countries.</recruitment_details>
      <pre_assignment_details>248 participants were randomized correctly to study, with an equal number of participants randomized to both treatment arms. The intention to treat (ITT) analysis set includes all participants who were correctly randomized into study. There are 5 screen failures who were not included in ITT analysis set because they were incorrectly randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rivaroxaban</title>
          <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Vitamin K Antagonist</title>
          <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
                <participants group_id="P2" count="124"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Rivaroxaban</title>
          <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Vitamin K Antagonist</title>
          <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="124"/>
            <count group_id="B2" value="124"/>
            <count group_id="B3" value="248"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.6" spread="9.86"/>
                    <measurement group_id="B2" value="60.5" spread="10.51"/>
                    <measurement group_id="B3" value="59.5" spread="10.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Great Britain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States of America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>ASIAN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLACK</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WHITE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>HISPANIC/LATINO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N/A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NOT HISPANIC/LATINO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body-Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.8" spread="5.74"/>
                    <measurement group_id="B2" value="28.9" spread="5.49"/>
                    <measurement group_id="B3" value="29.4" spread="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81" spread="9.85"/>
                    <measurement group_id="B2" value="79.4" spread="10.78"/>
                    <measurement group_id="B3" value="80.2" spread="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="133.3" spread="15.6"/>
                    <measurement group_id="B2" value="131.2" spread="17.68"/>
                    <measurement group_id="B3" value="132.2" spread="16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Incidence of Post-Procedure Major Bleeding Events</title>
        <description>Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.</description>
        <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
        <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban</title>
            <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist</title>
            <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incidence of Post-Procedure Major Bleeding Events</title>
          <description>Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.</description>
          <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TIMI Major Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISTH Major Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GUSTO Severe/Life Threatening Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death</title>
        <description>The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.</description>
        <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
        <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban</title>
            <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist</title>
            <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death</title>
          <description>The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.</description>
          <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Myocardial Infarction (MI)</title>
        <description>The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (&gt;) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.</description>
        <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
        <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban</title>
            <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist</title>
            <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Myocardial Infarction (MI)</title>
          <description>The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (&gt;) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.</description>
          <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Ischemic Stroke</title>
        <description>Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.</description>
        <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
        <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban</title>
            <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist</title>
            <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ischemic Stroke</title>
          <description>Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.</description>
          <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism</title>
        <description>The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).</description>
        <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
        <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban</title>
            <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist</title>
            <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism</title>
          <description>The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).</description>
          <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vascular Death</title>
        <description>Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.</description>
        <time_frame>Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure</time_frame>
        <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rivaroxaban</title>
            <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist</title>
            <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vascular Death</title>
          <description>Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.</description>
          <population>Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Screening up to Week 8-10</time_frame>
      <desc>The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rivaroxaban</title>
          <description>Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Vitamin K Antagonist</title>
          <description>Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 15.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Sinus arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Puncture site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Atonic seizures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 15.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director Clinical Development</name_or_title>
      <organization>Janssen Scientific Affairs, LLC</organization>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01729871
org study id: CR100732
secondary id: RIVAROXAFL3002
secondary id: 2012-001484-79
nct id: NCT01729871
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this exploratory study is to evaluate the safety of rivaroxaban and
      uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial
      fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major
      bleeding events.
This is a randomized (participants are assigned to intervention groups by chance), open-label
      (both physicians and participants know the identity of the assigned treatment),
      active-controlled, multi-center safety study of rivaroxaban or VKA before and after a
      catheter ablation procedure. This study requires collaboration with medical institutions that
      provide access to electrophysiologists who normally perform the catheter ablation procedure.
      In this study, NVAF is to be defined as the presence of AF in a person who does not have a
      prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or
      valvuloplasty are permitted) and who does not have hemodynamically significant mitral valve
      stenosis. Approximately 250 eligible participants, age 18 years or older, with a history of
      paroxysmal, persistent, or long standing persistent NVAF who are scheduled to undergo an
      elective catheter ablation procedure will be randomized in a 1:1 ratio to receive either
      rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal or VKA
      (adjusted to achieve a recommended International Normalized Ratio of 2.0 to 3.0).

      The study will consist of a screening period, a pre-procedure period, procedure period and
      post-procedure period. The screening period will begin up to 2 weeks prior to randomization.
      Participants will be randomized at the beginning of the pre-procedure period. During this
      period, participants will be recommended to receive their assigned treatment for at least 4
      weeks (maximum of 5 weeks) before the catheter ablation procedure. For participants with the
      sufficient anticoagulation, documented for the 3 weeks prior to randomization, and for
      participants with a transesophageal echocardiogram (TEE) or intracardiac echocardiography
      (ICE), the length of the pre-procedure period may be reduced down to 1-7 days and must
      include any transition from the previous anticoagulation therapy to randomized study drug.

      After the catheter ablation procedure, participants will receive their post-procedure dose of
      study drug through a minimum of 30 + - 5 days. In addition to scheduled visits and telephone
      calls the study may also include additional phone calls and visits by the participant to the
      site when dose adjustment is required for usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Incidence of Post-Procedure Major Bleeding Events
time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
description: Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.
measure: Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death
time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
description: The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.
measure: Number of Participants With Myocardial Infarction (MI)
time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
description: The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.
measure: Number of Participants With Ischemic Stroke
time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
description: Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.
measure: Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism
time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
description: The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).
measure: Number of Participants With Vascular Death
time frame: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
description: Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.
arm group label: rivaroxaban
arm group type: Experimental
description: rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal
arm group label: vitamin K antagonist (VKA)
arm group type: Experimental
description: dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
intervention type: Drug
intervention name: rivaroxaban
description: rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal
arm group label: rivaroxaban
intervention type: Drug
intervention name: uninterrupted vitamin K antagonist (VKA)
description: dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
arm group label: vitamin K antagonist (VKA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Scientific Affairs, LLC Clinical Trial
role: Study Director
affiliation: Janssen Scientific Affairs, LLC
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country: Belgium
country: France
country: Germany
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Vitamin K
mesh term: Rivaroxaban
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 