<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/NCT02975453</url>
  </required_header>
  <id_info>
    <org_study_id>18884</org_study_id>
    <nct_id>NCT02975453</nct_id>
  </id_info>
  <brief_title>Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban</brief_title>
  <acronym>EMIR</acronym>
  <official_title>Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial&#xD;
      fibrillation (NVAF) patients treated with rivaroxaban in Spain&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">August 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 18, 2020</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>2MACE score</measure>
    <time_frame>At baseline</time_frame>
    <description>MACE: Major adverse cardiovascular events. 2MACE: History of Myocardial infarction/ Cardiac revascularization and Metabolic Syndrome, Age &gt;75 years, Congestive heart failure (ejection fraction &lt;40%), Thrombo-Embolism</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of MACE to evaluate the performance of the 2MACE index</measure>
    <time_frame>At 2 years and 6 months or early termination</time_frame>
    <description>Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones</measure>
    <time_frame>At baseline</time_frame>
    <description>Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)</measure>
    <time_frame>At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of stroke</measure>
    <time_frame>At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of transient ischemic attack (TIA)</measure>
    <time_frame>At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of systemic embolism</measure>
    <time_frame>At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboembolic risk based on the CHADS2 score</measure>
    <time_frame>At baseline</time_frame>
    <description>CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboembolic risk based on the CHA2DS2-VASC</measure>
    <time_frame>At baseline</time_frame>
    <description>CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of MACEs occurring during the study</measure>
    <time_frame>At 1 year, at 2 years, at 2 years and 6 months or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' profile</measure>
    <time_frame>At baseline</time_frame>
    <description>Baseline patients' profile defined by: sociodemographic data, anthropometric data, previous relevant medical history, cardiac medical history distinct to atrial fibrillation, comorbidities (renal failure, left ventricular dysfunction, hypertension, thyroid dysfunction, liver failure, alcoholism)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1481</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban (Xarelto, BAY59-7939)</intervention_name>
    <description>As prescribed by the treating physician</description>
    <arm_group_label>Rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients diagnosed with non-valvular atrial fibrillation who are under rivaroxaban&#xD;
        treatment and that attend the Cardiology Units at Spanish hospitals and private clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients aged 18 years or older.&#xD;
&#xD;
          -  Patients with diagnosis of NVAF.&#xD;
&#xD;
          -  Patients treated with rivaroxaban from at least six months prior to the study&#xD;
             inclusion.&#xD;
&#xD;
          -  Patients who have been given appropriate information about the study objectives and&#xD;
             procedures and who have given their written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in an investigational program with interventions outside of&#xD;
             routine clinical practice.&#xD;
&#xD;
          -  Patients who initiate treatment with rivaroxaban after the start of the study&#xD;
             inclusion period.&#xD;
&#xD;
          -  Prosthetic heart valves or the presence of any severe valvulopathies.&#xD;
&#xD;
          -  Patients with severe cognitive impairment.&#xD;
&#xD;
          -  Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus)&#xD;
             or systemic autoimmune diseases.&#xD;
&#xD;
          -  Patients with active cancer.&#xD;
&#xD;
          -  Patients with liver insufficiency (eg. cirrhosis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Multiple Locations</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</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>July 2021</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975453
org study id: 18884
nct id: NCT02975453
lead sponsor: 
collaborator: 
has dmc: No
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial
      fibrillation (NVAF) patients treated with rivaroxaban in Spain
observational model: Cohort
time perspective: Prospective
measure: 2MACE score
time frame: At baseline
description: MACE: Major adverse cardiovascular events. 2MACE: History of Myocardial infarction/ Cardiac revascularization and Metabolic Syndrome, Age >75 years, Congestive heart failure (ejection fraction <40%), Thrombo-Embolism
measure: Occurrence of MACE to evaluate the performance of the 2MACE index
time frame: At 2 years and 6 months or early termination
description: Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death
measure: Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones
time frame: At baseline
description: Risk factors to the 2MACE index (e.g. body mass index, smoking, drugs use, estimated glomerular filtration rate, structural cardio-pathology)
measure: Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)
time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Occurrence of stroke
time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Occurrence of transient ischemic attack (TIA)
time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Occurrence of systemic embolism
time frame: At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Thromboembolic risk based on the CHADS2 score
time frame: At baseline
description: CHADS2: Cardiac Failure, Hypertension, Age, Diabetes, Stroke
measure: Thromboembolic risk based on the CHA2DS2-VASC
time frame: At baseline
description: CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and Sex category
measure: Number of MACEs occurring during the study
time frame: At 1 year, at 2 years, at 2 years and 6 months or early termination
measure: Patients' profile
time frame: At baseline
description: Baseline patients' profile defined by: sociodemographic data, anthropometric data, previous relevant medical history, cardiac medical history distinct to atrial fibrillation, comorbidities (renal failure, left ventricular dysfunction, hypertension, thyroid dysfunction, liver failure, alcoholism)
measure: Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization
time frame: At baseline
arm group label: Rivaroxaban
description: Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion
intervention type: Drug
intervention name: Rivaroxaban (Xarelto, BAY59-7939)
description: As prescribed by the treating physician
arm group label: Rivaroxaban
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Spain
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: Rivaroxaban