<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/NCT04401761</url>
  </required_header>
  <id_info>
    <org_study_id>21283</org_study_id>
    <nct_id>NCT04401761</nct_id>
  </id_info>
  <brief_title>A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs</brief_title>
  <acronym>XATOC</acronym>
  <official_title>Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together&#xD;
      with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery&#xD;
      disease (a condition that affects the blood vessels supplying the heart) and / or peripheral&#xD;
      artery disease (a condition that affects the blood vessels of the lower limbs) in the routine&#xD;
      clinical practice. The study will help to collect data for prevention cardiovascular death,&#xD;
      myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study&#xD;
      will focus on information on when and why physicians are starting to treat patients with&#xD;
      combination therapy, treatment duration, reasons to discontinue treatment and previous&#xD;
      therapies. The study will also investigate treatment outcomes for patients being treated with&#xD;
      a combination therapy by their physicians.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</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>Health status by questionnaire EQ-5D-5L</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Self-reported health-related quality of life is measured with EQ-5D at the initial visit and at each follow-up visit. Items are scored from 1 (no problems) to 5 (extreme problems) leading to a total score from 0 (worst imaginable health) to 100 (best imaginable health).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of clinical characteristics of CAD participants</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of clinical characteristics of PAD participants</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of prior antithrombotic treatment</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of concomitant antithrombotic treatment</measure>
    <time_frame>Upto 34 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of prior secondary prevention therapies</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of concomitant secondary prevention therapies</measure>
    <time_frame>Up to 34 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reason to start rivaroxaban</measure>
    <time_frame>At baseline</time_frame>
    <description>Reasons include past ischemic events, co-morbidities and medical history.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision point to start rivaroxaban</measure>
    <time_frame>At baseline</time_frame>
    <description>Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for discontinuation of rivaroxaban</measure>
    <time_frame>Up to 34 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Planned duration of treatment with rivaroxaban</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual duration of treatment with rivaroxaban</measure>
    <time_frame>Up to 34 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Planned duration of treatment with Acetylsalicylic acid (ASA)</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual duration of treatment with ASA</measure>
    <time_frame>Up to 34 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with major adverse cardiovascular events (MACE)</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with major adverse limb events (MALE)</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment [pattern] after MALE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with antithrombotic treatment after MALE</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with MACE or MALE</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with thromboembolic events</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Thromboembolic events include e.g. systemic embolism and venous thromboembolism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with haemorrhagic events and complications</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>The major bleeding complications will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, modified ISTH criteria, and Thrombolysis in Myocardial Infarction (TIMI) criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of deaths due to cardiovascular events</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of deaths due to any cause</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with cardiac revascularization procedures</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with peripheral revascularization procedures</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with lower limb revascularization procedures.</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with carotid revascularization procedures</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalizations</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total walking distance per individual for PAD participants</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain free walking distance per individual for PAD participants</measure>
    <time_frame>Up to 34 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants</measure>
    <time_frame>Up to 34 months</time_frame>
    <description>The WIQ is a validated questionnaire that measures patient-reported walking limitations in distance, stair climbing and speed. Final score ranges from 0 (unable to walk) to 4 (no difficulty to walk).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3189</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>CAD/PAD-patients</arm_group_label>
    <description>Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (BAY59-7939, Xarelto)</intervention_name>
    <description>2.5 mg twice daily</description>
    <arm_group_label>CAD/PAD-patients</arm_group_label>
    <other_name>Xarelto</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetylsalicylic acid</intervention_name>
    <description>75 - 100 mg once daily at the discretion of the investigator</description>
    <arm_group_label>CAD/PAD-patients</arm_group_label>
    <other_name>Aspirin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        International population of adult CAD/PAD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥18 years) patient (except Taiwan ≥ 20 years old).&#xD;
&#xD;
          -  Diagnosis of CAD or symptomatic PAD.&#xD;
&#xD;
          -  Treatment according to local marketing authorization, rivaroxaban 2.5 mg [BID] plus&#xD;
             Acetylsalicylic acid (ASA) 75-100 mg [OD] started up to 4 weeks before or after the&#xD;
             ICF is signed.&#xD;
&#xD;
          -  Only in those countries with a marketing authorization of rivaroxaban in the Acute&#xD;
             Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS&#xD;
             for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also&#xD;
             allowed to be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra-indications according to the local marketing authorization.&#xD;
&#xD;
          -  Patients who will be treated with chronic anticoagulation therapy other than&#xD;
             rivaroxaban 2.5 mg given for CAD/PAD.&#xD;
&#xD;
          -  Participation in an interventional trial.&#xD;
&#xD;
          -  Enrolment in the XATOA study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Russian Federation</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Saudi Arabia</country>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers 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.&#xD;
Interested researchers can use www.vivli.org 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 member 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/NCT04401761
org study id: 21283
nct id: NCT04401761
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together
      with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery
      disease (a condition that affects the blood vessels supplying the heart) and / or peripheral
      artery disease (a condition that affects the blood vessels of the lower limbs) in the routine
      clinical practice. The study will help to collect data for prevention cardiovascular death,
      myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study
      will focus on information on when and why physicians are starting to treat patients with
      combination therapy, treatment duration, reasons to discontinue treatment and previous
      therapies. The study will also investigate treatment outcomes for patients being treated with
      a combination therapy by their physicians.
observational model: Cohort
time perspective: Prospective
measure: Health status by questionnaire EQ-5D-5L
time frame: Up to 34 months
description: Self-reported health-related quality of life is measured with EQ-5D at the initial visit and at each follow-up visit. Items are scored from 1 (no problems) to 5 (extreme problems) leading to a total score from 0 (worst imaginable health) to 100 (best imaginable health).
measure: Descriptive analysis of clinical characteristics of CAD participants
time frame: At baseline
measure: Descriptive analysis of clinical characteristics of PAD participants
time frame: At baseline
measure: Descriptive analysis of prior antithrombotic treatment
time frame: At baseline
measure: Descriptive analysis of concomitant antithrombotic treatment
time frame: Upto 34 months
measure: Descriptive analysis of prior secondary prevention therapies
time frame: At baseline
measure: Descriptive analysis of concomitant secondary prevention therapies
time frame: Up to 34 months
measure: Reason to start rivaroxaban
time frame: At baseline
description: Reasons include past ischemic events, co-morbidities and medical history.
measure: Decision point to start rivaroxaban
time frame: At baseline
description: Time point of start of medication in relation to disease progress and/ or occurrence of ischemic events
measure: Reasons for discontinuation of rivaroxaban
time frame: Up to 34 months
measure: Planned duration of treatment with rivaroxaban
time frame: At baseline
measure: Actual duration of treatment with rivaroxaban
time frame: Up to 34 months
measure: Planned duration of treatment with Acetylsalicylic acid (ASA)
time frame: At baseline
measure: Actual duration of treatment with ASA
time frame: Up to 34 months
measure: Number of participants with major adverse cardiovascular events (MACE)
time frame: Up to 34 months
description: Composite endpoint comprising of myocardial infarction, stroke, and cardiovascular death (and single components).
measure: Number of participants with major adverse limb events (MALE)
time frame: Up to 34 months
description: Major adverse limb events comprise acute limb ischemia and vascular amputation, and antithrombotic treatment [pattern] after MALE.
measure: Number of participants with antithrombotic treatment after MALE
time frame: Up to 34 months
measure: Number of participants with MACE or MALE
time frame: Up to 34 months
description: Composite endpoint comprising myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, major amputation of vascular etiology.
measure: Number of participants with thromboembolic events
time frame: Up to 34 months
description: Thromboembolic events include e.g. systemic embolism and venous thromboembolism.
measure: Number of participants with haemorrhagic events and complications
time frame: Up to 34 months
description: The major bleeding complications will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria, modified ISTH criteria, and Thrombolysis in Myocardial Infarction (TIMI) criteria.
measure: Number of deaths due to cardiovascular events
time frame: Up to 34 months
measure: Number of deaths due to any cause
time frame: Up to 34 months
measure: Number of participants with cardiac revascularization procedures
time frame: Up to 34 months
description: Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
measure: Number of participants with peripheral revascularization procedures
time frame: Up to 34 months
measure: Number of participants with lower limb revascularization procedures.
time frame: Up to 34 months
measure: Number of participants with carotid revascularization procedures
time frame: Up to 34 months
measure: Number of hospitalizations
time frame: Up to 34 months
description: Number of hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
measure: Duration of hospitalizations
time frame: Up to 34 months
description: Hospitalizations due to stroke, cardiovascular reasons, MALE, or bleeding complications.
measure: Total walking distance per individual for PAD participants
time frame: Up to 34 months
measure: Pain free walking distance per individual for PAD participants
time frame: Up to 34 months
measure: Patient-reported walking impairment by Walking Impairment Questionnaire (WIQ) for PAD participants
time frame: Up to 34 months
description: The WIQ is a validated questionnaire that measures patient-reported walking limitations in distance, stair climbing and speed. Final score ranges from 0 (unable to walk) to 4 (no difficulty to walk).
arm group label: CAD/PAD-patients
description: Adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are treated with a combination of rivaroxaban and acetylsalicylic acid.
intervention type: Drug
intervention name: Rivaroxaban (BAY59-7939, Xarelto)
description: 2.5 mg twice daily
arm group label: CAD/PAD-patients
other name: Xarelto
intervention type: Drug
intervention name: Acetylsalicylic acid
description: 75 - 100 mg once daily at the discretion of the investigator
arm group label: CAD/PAD-patients
other name: Aspirin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: China
country: Colombia
country: Italy
country: Korea, Republic of
country: Russian Federation
country: Slovenia
country: Spain
country: Switzerland
country: Taiwan
country: Brazil
country: Canada
country: Saudi Arabia
country: United Kingdom
url: https://clinicaltrials.bayer.com/
description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Peripheral Arterial Disease
mesh term: Aspirin
mesh term: Rivaroxaban
sharing ipd: No
ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers 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.vivli.org 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 member section of the portal.