<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/NCT03285373</url>
  </required_header>
  <id_info>
    <org_study_id>1160-0287</org_study_id>
    <nct_id>NCT03285373</nct_id>
  </id_info>
  <brief_title>This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain</brief_title>
  <acronym>RE-CONOCE</acronym>
  <official_title>Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to describe the usage of NOACs in patients with NVAF,&#xD;
      in the hospital setting, based on the baseline characteristics at the time of first NOAC&#xD;
      initiation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation</measure>
    <time_frame>Start of the first NOAC treatment</time_frame>
    <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation</measure>
    <time_frame>Start of the first NOAC treatment</time_frame>
    <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation.&#xD;
The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation</measure>
    <time_frame>Start of the first NOAC treatment</time_frame>
    <description>Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation.&#xD;
The total CHA2DS2-VASc Scores score was stratified by category according to the following classification:&#xD;
Low risk (score 0 in male; score 1 in female)&#xD;
Moderate risk (score 1 in male; score 2 in female)&#xD;
High risk (score ≥2 in male; score ≥3 in female)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation</measure>
    <time_frame>Start of the first NOAC treatment</time_frame>
    <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation</measure>
    <time_frame>Start of the first NOAC treatment</time_frame>
    <description>Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation.&#xD;
The total HAS-BLED Score was stratified by category according to the following classification:&#xD;
Low risk (score 0)&#xD;
Moderate risk (score 1-2)&#xD;
High risk (score ≥3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appropriateness of NOACs Prescription</measure>
    <time_frame>single visit (Day 1)</time_frame>
    <description>Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met.&#xD;
Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Visits to the Physician Per Year</measure>
    <time_frame>1 year (data collected during single visit on day 1)</time_frame>
    <description>Mean number of visits to the physician per year considered for the NOAC Management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of First NOAC, All NOAC and Subsequent NOAC Treatment</measure>
    <time_frame>Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.</time_frame>
    <description>Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC</measure>
    <time_frame>single visit (Day 1)</time_frame>
    <description>Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose</measure>
    <time_frame>single visit (Day 1)</time_frame>
    <description>Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for Treatment Changes</measure>
    <time_frame>Start of the first NOAC treatment</time_frame>
    <description>Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Previous Treatment With Vitamin K Antagonists</measure>
    <time_frame>single visit (Day 1)</time_frame>
    <description>Number of patient with Previous Treatment with Vitamin K Antagonists.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Previous VKA Treatment</measure>
    <time_frame>Through the observational period with an average of 43.8 months, data collected during a single visit.</time_frame>
    <description>Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Knowledge About His Condition</measure>
    <time_frame>single visit (Day 1)</time_frame>
    <description>At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed.&#xD;
Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1008</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>patients with NVAF</arm_group_label>
    <description>patients with Non Valvular Atrial Fibrillation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NOAC</intervention_name>
    <description>New Oral Anticoagulant</description>
    <arm_group_label>patients with NVAF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 1.000 patients with NVAF currently on NOAC treatment and having initiated&#xD;
        their first NOAC starting from November 2016 (Health Authorities positioning report&#xD;
        publication) are planned to be included in the study. To minimize selection bias at the&#xD;
        patient level, 10 consecutive patients from each site who meet entry criteria will be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is willing and provides written informed consent to participate in this&#xD;
             study&#xD;
&#xD;
          -  The patient is at least 18 years of age&#xD;
&#xD;
          -  The patient has a diagnosis of non-valvular atrial fibrillation (NVAF)&#xD;
&#xD;
          -  The patient is on treatment with NOAC according to its approved local SmPC and has&#xD;
             initiated his first NOAC starting from November 2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -if the current participating patient participate in any clinical trial of a drug or device&#xD;
        will be excluded&#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>Mireia Canals, +34607550925</last_name>
    <role>Study Chair</role>
    <affiliation>mireia.canals@boehringer-ingelheim.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clínica Modelo</name>
      <address>
        <city>A Coruña</city>
        <zip>15011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universatio de Albacete</name>
      <address>
        <city>Albacete</city>
        <zip>2006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quirónsalud Sur</name>
      <address>
        <city>Alcorcón (Madrid)</city>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. José Molina Orosa</name>
      <address>
        <city>Arrecife, Las Palmas</city>
        <zip>35500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H de Cabueñes</name>
      <address>
        <city>Asturias</city>
        <zip>33394</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Cristina</name>
      <address>
        <city>Badajoz</city>
        <zip>06080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Sagrada Familia</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Barcelona</city>
        <zip>08037</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>8003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>8003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Residencia Sant Camil</name>
      <address>
        <city>Barcelona</city>
        <zip>8810</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Moisés Broggi</name>
      <address>
        <city>Barcelona</city>
        <zip>8970</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Basurto</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H Aranda Duero</name>
      <address>
        <city>Burgos</city>
        <zip>9400</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Castellón</city>
        <zip>12540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cáceres</name>
      <address>
        <city>Cáceres</city>
        <zip>10004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Córdoba</city>
        <zip>14005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Córdoba</city>
        <zip>14006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Puerto</name>
      <address>
        <city>El Puerto De Santa Maria (Cádiz)</city>
        <zip>11500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Elche</name>
      <address>
        <city>Elche (Alicante)</city>
        <zip>03202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vinalopo Salud</name>
      <address>
        <city>Elche (Alicante)</city>
        <zip>03293</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital García Orcoyen</name>
      <address>
        <city>Estella (Navarra)</city>
        <zip>31200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Del Río Estepona y San Pedro</name>
      <address>
        <city>Estepona (Málaga)</city>
        <zip>29680</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Arquitecto Marcide</name>
      <address>
        <city>Ferrol (A Coruña)</city>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Galdakao</name>
      <address>
        <city>Galdakao (Vizcaya)</city>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Gandía (Valencia)</city>
        <zip>46702</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vithas La Salud</name>
      <address>
        <city>Granada</city>
        <zip>18008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Granollers (Barcelona)</city>
        <zip>08402</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. U. Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <zip>19002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Hospitalet De Ll (Barcelona)</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Juan Ramon Jiménez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Huesca</city>
        <zip>22005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Universitario Dr. Negrín</name>
      <address>
        <city>Las Palmas</city>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General San Agustin</name>
      <address>
        <city>Linares (Jaen)</city>
        <zip>23700</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Señora del Rosario</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Quirón Salud H. Sur Alcorcón</name>
      <address>
        <city>Madrid</city>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta del Hierro</name>
      <address>
        <city>Majadahonda (Madrid)</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Manises</name>
      <address>
        <city>Manises (Valencia)</city>
        <zip>36940</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ochoa</name>
      <address>
        <city>Marbella (Málaga)</city>
        <zip>29602</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Mataró</name>
      <address>
        <city>Mataró (Barcelona)</city>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Mérida</name>
      <address>
        <city>Mérida</city>
        <zip>6800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo (Asturias)</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Son Llatzer</name>
      <address>
        <city>Palma De Mallorca (Baleares)</city>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quirón Campo de Gibraltar</name>
      <address>
        <city>Palmones (Cádiz)</city>
        <zip>11379</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Especialidades Dr. San Martin</name>
      <address>
        <city>Pamplona</city>
        <zip>31004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Pontevedra</name>
      <address>
        <city>Pontevedra</city>
        <zip>36078</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Parc Taulí</name>
      <address>
        <city>Sabadell (Barcelona)</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. C. U. Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlínic Sant Cugat</name>
      <address>
        <city>Sant Cugat Del Valles (Barcelona)</city>
        <zip>08172</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela (A Coruña)</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago</name>
      <address>
        <city>Santiago De Compostela (A Coruña)</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela (A Coruña)</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Duque del Infantado</name>
      <address>
        <city>Sevilla</city>
        <zip>41012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Practice</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Santa Bárbara</name>
      <address>
        <city>Soria</city>
        <zip>42005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Tarragona Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <zip>43005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Señora de la Candelaria</name>
      <address>
        <city>Tenerife</city>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo H. Universitario de Canarias</name>
      <address>
        <city>Tenerife</city>
        <zip>38302</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HM Hospitales Madrid</name>
      <address>
        <city>Torrelodones (Madrid)</city>
        <zip>28250</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Santa Elena</name>
      <address>
        <city>Torremolinos (Málaga)</city>
        <zip>29620</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pius Hospital de Valls</name>
      <address>
        <city>Valls (Tarragona)</city>
        <zip>43800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de La Plana</name>
      <address>
        <city>Vila-Real (Castellón)</city>
        <zip>12540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Lluis Alcanyis</name>
      <address>
        <city>Xàtiva (Valencia)</city>
        <zip>46800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial de Zamora</name>
      <address>
        <city>Zamora</city>
        <zip>49022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Clínico Universitario</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Royo Villanova</name>
      <address>
        <city>Zaragoza</city>
        <zip>50015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 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 18, 2017</study_first_posted>
  <results_first_submitted>January 8, 2020</results_first_submitted>
  <results_first_submitted_qc>January 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2020</results_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03285373/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03285373/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients with Non Valvular Atrial Fibrillation (NVAF) in Spain, mainly from the hospital setting were on treatment with New Oral Anticoagulant (NOAC) according to its approved local Summary of Product Characteristics (SmPC) and have initiated their first NOAC starting from November 2016 were included in this trial.</recruitment_details>
      <pre_assignment_details>All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites in Spain to ensure that subjects met all incl/excl criteria. 45 patients (out of 1008 enrolled), did not meet at least one of the selection criteria and were considered not eligible. Data analysis was carried out with 963 eligible patients.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran</title>
          <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
        </group>
        <group group_id="P2">
          <title>Rivaroxaban</title>
          <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
        </group>
        <group group_id="P3">
          <title>Apixaban</title>
          <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
        </group>
        <group group_id="P4">
          <title>Edoxaban</title>
          <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="314"/>
                <participants group_id="P2" count="253"/>
                <participants group_id="P3" count="266"/>
                <participants group_id="P4" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="314"/>
                <participants group_id="P2" count="253"/>
                <participants group_id="P3" count="266"/>
                <participants group_id="P4" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).</population>
      <group_list>
        <group group_id="B1">
          <title>All Patients</title>
          <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="963"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age at baseline visit.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="963"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.6" spread="10.1"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="963"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="406"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation</title>
        <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.</description>
        <time_frame>Start of the first NOAC treatment</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation</title>
          <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="266"/>
                <count group_id="O4" value="130"/>
                <count group_id="O5" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="9.9"/>
                    <measurement group_id="O2" value="72.5" spread="10.7"/>
                    <measurement group_id="O3" value="72.6" spread="9.8"/>
                    <measurement group_id="O4" value="74.0" spread="10.0"/>
                    <measurement group_id="O5" value="72.8" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation</title>
        <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation.&#xD;
The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.</description>
        <time_frame>Start of the first NOAC treatment</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation</title>
          <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (&gt; 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation.&#xD;
The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.</population>
          <units>Unit on Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="254"/>
                <count group_id="O4" value="129"/>
                <count group_id="O5" value="942"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="1.5"/>
                    <measurement group_id="O2" value="3.3" spread="1.6"/>
                    <measurement group_id="O3" value="3.3" spread="1.5"/>
                    <measurement group_id="O4" value="3.3" spread="1.5"/>
                    <measurement group_id="O5" value="3.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation</title>
        <description>Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation.&#xD;
The total CHA2DS2-VASc Scores score was stratified by category according to the following classification:&#xD;
Low risk (score 0 in male; score 1 in female)&#xD;
Moderate risk (score 1 in male; score 2 in female)&#xD;
High risk (score ≥2 in male; score ≥3 in female)</description>
        <time_frame>Start of the first NOAC treatment</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation</title>
          <description>Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation.&#xD;
The total CHA2DS2-VASc Scores score was stratified by category according to the following classification:&#xD;
Low risk (score 0 in male; score 1 in female)&#xD;
Moderate risk (score 1 in male; score 2 in female)&#xD;
High risk (score ≥2 in male; score ≥3 in female)</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="254"/>
                <count group_id="O4" value="129"/>
                <count group_id="O5" value="942"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Low risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="21"/>
                    <measurement group_id="O5" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="252"/>
                    <measurement group_id="O2" value="207"/>
                    <measurement group_id="O3" value="215"/>
                    <measurement group_id="O4" value="108"/>
                    <measurement group_id="O5" value="782"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation</title>
        <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.</description>
        <time_frame>Start of the first NOAC treatment</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation</title>
          <description>Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (&gt;65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.</population>
          <units>unit on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="128"/>
                <count group_id="O5" value="940"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.0"/>
                    <measurement group_id="O2" value="1.8" spread="1.1"/>
                    <measurement group_id="O3" value="1.7" spread="1.1"/>
                    <measurement group_id="O4" value="1.8" spread="1.0"/>
                    <measurement group_id="O5" value="1.8" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation</title>
        <description>Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation.&#xD;
The total HAS-BLED Score was stratified by category according to the following classification:&#xD;
Low risk (score 0)&#xD;
Moderate risk (score 1-2)&#xD;
High risk (score ≥3)</description>
        <time_frame>Start of the first NOAC treatment</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation</title>
          <description>Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation.&#xD;
The total HAS-BLED Score was stratified by category according to the following classification:&#xD;
Low risk (score 0)&#xD;
Moderate risk (score 1-2)&#xD;
High risk (score ≥3)</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="308"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="128"/>
                <count group_id="O5" value="940"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Low risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219"/>
                    <measurement group_id="O2" value="157"/>
                    <measurement group_id="O3" value="170"/>
                    <measurement group_id="O4" value="86"/>
                    <measurement group_id="O5" value="632"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="56"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Appropriateness of NOACs Prescription</title>
        <description>Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met.&#xD;
Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.</description>
        <time_frame>single visit (Day 1)</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Appropriateness of NOACs Prescription</title>
          <description>Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met.&#xD;
Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Reason 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="271"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="342"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reason 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Number of Visits to the Physician Per Year</title>
        <description>Mean number of visits to the physician per year considered for the NOAC Management.</description>
        <time_frame>1 year (data collected during single visit on day 1)</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Visits to the Physician Per Year</title>
          <description>Mean number of visits to the physician per year considered for the NOAC Management.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>visits per year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of First NOAC, All NOAC and Subsequent NOAC Treatment</title>
        <description>Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).</description>
        <time_frame>Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of First NOAC, All NOAC and Subsequent NOAC Treatment</title>
          <description>Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First NOAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All NOAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subsequent NOAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC</title>
        <description>Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC</description>
        <time_frame>single visit (Day 1)</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC</title>
          <description>Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discontinue treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose adjustment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change to a new NOAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="907"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose</title>
        <description>Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.</description>
        <time_frame>single visit (Day 1)</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who changed to a new NOAC. As per protocol this endpoint was to be analysed overall for all eligible patients who changed to a new NOAC. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose</title>
          <description>Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who changed to a new NOAC. As per protocol this endpoint was to be analysed overall for all eligible patients who changed to a new NOAC. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Dabigatran 110 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dabigatran 150 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rivaroxaban 10 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rivaroxaban 15 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rivaroxaban 20 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Apixaban 2.5 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Apixaban 5 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Edoxaban 30 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Edoxaban 60 mg</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reason for Treatment Changes</title>
        <description>Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.</description>
        <time_frame>Start of the first NOAC treatment</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who required treatment changes.As per protocol this endpoint was to be analysed overall for all eligible patients who required treatment changes. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Reason for Treatment Changes</title>
          <description>Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who required treatment changes.As per protocol this endpoint was to be analysed overall for all eligible patients who required treatment changes. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigator decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Previous Treatment With Vitamin K Antagonists</title>
        <description>Number of patient with Previous Treatment with Vitamin K Antagonists.</description>
        <time_frame>single visit (Day 1)</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Previous Treatment With Vitamin K Antagonists</title>
          <description>Number of patient with Previous Treatment with Vitamin K Antagonists.</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="253"/>
                <count group_id="O3" value="266"/>
                <count group_id="O4" value="130"/>
                <count group_id="O5" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="125"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="53"/>
                    <measurement group_id="O5" value="424"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="128"/>
                    <measurement group_id="O3" value="166"/>
                    <measurement group_id="O4" value="77"/>
                    <measurement group_id="O5" value="539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Previous VKA Treatment</title>
        <description>Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC</description>
        <time_frame>Through the observational period with an average of 43.8 months, data collected during a single visit.</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed only for patients with previous VKA treatment (n=424). Dates of start and/or stop of previous VKA treatment were not available for 62 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
          </group>
          <group group_id="O2">
            <title>Rivaroxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.</description>
          </group>
          <group group_id="O3">
            <title>Apixaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.</description>
          </group>
          <group group_id="O4">
            <title>Edoxaban</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.</description>
          </group>
          <group group_id="O5">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Previous VKA Treatment</title>
          <description>Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed only for patients with previous VKA treatment (n=424). Dates of start and/or stop of previous VKA treatment were not available for 62 patients.</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="107"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="50"/>
                <count group_id="O5" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" spread="52.5"/>
                    <measurement group_id="O2" value="37.0" spread="50.6"/>
                    <measurement group_id="O3" value="54.5" spread="58.9"/>
                    <measurement group_id="O4" value="34.0" spread="47.9"/>
                    <measurement group_id="O5" value="43.8" spread="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Knowledge About His Condition</title>
        <description>At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed.&#xD;
Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?</description>
        <time_frame>single visit (Day 1)</time_frame>
        <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients</title>
            <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Knowledge About His Condition</title>
          <description>At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed.&#xD;
Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?</description>
          <population>The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="963"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question 1.</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="845"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2.</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="820"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3.</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="766"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4.</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="333"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Informed consent signed until the end of the trial, up to 12 months.</time_frame>
      <desc>The study design was of non-interventional nature and the study was conducted within the conditions of the approved marketing authorization. Sufficient data were available to support the evidence on the safety and efficacy of the studied BI drug. For this reason Adverse Drug Reactions (ADR) and fatal Adverse Events (AE) were only collected for one of the NOACs (dabigatran). No data was collected for the other NOACs (Rivaroxaban, Apixaban and Edoxaban) reported on in this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran</title>
          <description>Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="314"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="314"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="314"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="314"/>
              </event>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="314"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="314"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT03285373
org study id: 1160-0287
nct id: NCT03285373
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to describe the usage of NOACs in patients with NVAF,
      in the hospital setting, based on the baseline characteristics at the time of first NOAC
      initiation.
observational model: Cohort
time perspective: Cross-Sectional
measure: Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
time frame: Start of the first NOAC treatment
description: Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.
measure: Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
time frame: Start of the first NOAC treatment
description: Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation.
The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
measure: Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
time frame: Start of the first NOAC treatment
description: Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation.
The total CHA2DS2-VASc Scores score was stratified by category according to the following classification:
Low risk (score 0 in male; score 1 in female)
Moderate risk (score 1 in male; score 2 in female)
High risk (score ≥2 in male; score ≥3 in female)
measure: Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation
time frame: Start of the first NOAC treatment
description: Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.
measure: Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation
time frame: Start of the first NOAC treatment
description: Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation.
The total HAS-BLED Score was stratified by category according to the following classification:
Low risk (score 0)
Moderate risk (score 1-2)
High risk (score ≥3)
measure: Appropriateness of NOACs Prescription
time frame: single visit (Day 1)
description: Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met.
Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.
measure: Mean Number of Visits to the Physician Per Year
time frame: 1 year (data collected during single visit on day 1)
description: Mean number of visits to the physician per year considered for the NOAC Management.
measure: Duration of First NOAC, All NOAC and Subsequent NOAC Treatment
time frame: Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.
description: Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).
measure: Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC
time frame: single visit (Day 1)
description: Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC
measure: Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose
time frame: single visit (Day 1)
description: Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.
measure: Reason for Treatment Changes
time frame: Start of the first NOAC treatment
description: Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.
measure: Number of Patients With Previous Treatment With Vitamin K Antagonists
time frame: single visit (Day 1)
description: Number of patient with Previous Treatment with Vitamin K Antagonists.
measure: Duration of Previous VKA Treatment
time frame: Through the observational period with an average of 43.8 months, data collected during a single visit.
description: Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC
measure: Patient's Knowledge About His Condition
time frame: single visit (Day 1)
description: At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed.
Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?
arm group label: patients with NVAF
description: patients with Non Valvular Atrial Fibrillation
intervention type: Drug
intervention name: NOAC
description: New Oral Anticoagulant
arm group label: patients with NVAF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mireia Canals, +34607550925
role: Study Chair
affiliation: mireia.canals@boehringer-ingelheim.com
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country: Spain
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
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