<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/NCT03284762</url>
  </required_header>
  <id_info>
    <org_study_id>18981</org_study_id>
    <nct_id>NCT03284762</nct_id>
  </id_info>
  <brief_title>Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation</brief_title>
  <acronym>XaMINA</acronym>
  <official_title>Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of the study is to collect additional information of Xarelto treatment in routine&#xD;
      clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a&#xD;
      prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial&#xD;
      Fibrillation) will be observed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be&#xD;
      included in the study within 12 months. The observation period for each patient is 1 year&#xD;
      from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients&#xD;
      will be followed according to routine medical practice and the frequency of visits and&#xD;
      procedures will be performed under routine conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)</measure>
    <time_frame>Up to one year</time_frame>
    <description>Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with:&#xD;
A fall in hemoglobin of ≥2 g/dL, or&#xD;
A transfusion of ≥2 units of packed red blood cells or whole blood, or&#xD;
Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or&#xD;
Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AEs</measure>
    <time_frame>Up to one year</time_frame>
    <description>All events which do not fall under characterization of major bleeding events as explained in section &quot;primary outcome variables&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SAEs</measure>
    <time_frame>Up to one year</time_frame>
    <description>All events which do not fall under characterization of major bleeding events as explained in section &quot;primary outcome variables&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Up to one year</time_frame>
    <description>All events which do not fall under characterization of major bleeding events as explained in section &quot;primary outcome variables&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-major bleeding events</measure>
    <time_frame>Up to one year</time_frame>
    <description>All events which do not fall under characterization of major bleeding events as explained in section &quot;primary outcome variables&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic thromboembolic events</measure>
    <time_frame>Up to one year</time_frame>
    <description>All events which do not fall under characterization of major bleeding events as explained in section &quot;primary outcome variables&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy</measure>
    <time_frame>Up to one year</time_frame>
    <description>Start date and stop date will be collected to receive information on drug persistence</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1216</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Treatment-naïve NVAF patients in Korea and Taiwan</arm_group_label>
    <description>Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function</description>
    <arm_group_label>Treatment-naïve NVAF patients in Korea and Taiwan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for&#xD;
        treatment of atrial fibrillation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and male patients aged 19 years or older (Korea) and aged 20 years or older&#xD;
             (Taiwan)&#xD;
&#xD;
          -  Diagnosis of NVAF&#xD;
&#xD;
          -  Patients for whom the decision to initiate treatment with rivaroxaban is made as per&#xD;
             physician's routine treatment practice&#xD;
&#xD;
          -  Treatment naïve regarding stroke prevention for atrial fibrillation&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for rivaroxaban according to the local market authorization/summary&#xD;
             of product characteristics (SmPC)&#xD;
&#xD;
          -  Patients participating in an investigational program with interventions outside of&#xD;
             routine clinical practice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Different facilities</name>
      <address>
        <city>Multiple Locations</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Different facilities</name>
      <address>
        <city>Multiple Locations</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284762
org study id: 18981
nct id: NCT03284762
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to collect additional information of Xarelto treatment in routine
      clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a
      prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial
      Fibrillation) will be observed.
The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be
      included in the study within 12 months. The observation period for each patient is 1 year
      from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients
      will be followed according to routine medical practice and the frequency of visits and
      procedures will be performed under routine conditions.
observational model: Cohort
time perspective: Prospective
measure: Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
time frame: Up to one year
description: Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with:
A fall in hemoglobin of ≥2 g/dL, or
A transfusion of ≥2 units of packed red blood cells or whole blood, or
Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or
Death.
measure: AEs
time frame: Up to one year
description: All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
measure: SAEs
time frame: Up to one year
description: All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
measure: All-cause mortality
time frame: Up to one year
description: All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
measure: Non-major bleeding events
time frame: Up to one year
description: All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
measure: Symptomatic thromboembolic events
time frame: Up to one year
description: All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
measure: Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
time frame: Up to one year
description: Start date and stop date will be collected to receive information on drug persistence
arm group label: Treatment-naïve NVAF patients in Korea and Taiwan
description: Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function
arm group label: Treatment-naïve NVAF patients in Korea and Taiwan
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Korea, Republic of
country: Taiwan
url: http://clinicaltrials.bayer.com
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Embolism
mesh term: Rivaroxaban
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.