<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/NCT04419012</url>
  </required_header>
  <id_info>
    <org_study_id>104/018</org_study_id>
    <nct_id>NCT04419012</nct_id>
  </id_info>
  <brief_title>Polish Atrial Fibrillation (POL-AF) Registry</brief_title>
  <acronym>POL-AF</acronym>
  <official_title>Polish Atrial Fibrillation (POL-AF) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jan Kochanowski University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jan Kochanowski University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients&#xD;
      with atrial fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular&#xD;
      mortality. An important element of management of patients with AF is anticoagulation to&#xD;
      prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) and vitamin K&#xD;
      antagonists (VKAs) are two main drugs groups used in thromboembolic events prevention.&#xD;
&#xD;
      Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF&#xD;
      patients treatment of with OACs.&#xD;
&#xD;
      Secondary objective of the study are as follows: assessment of the frequency of&#xD;
      appropriate/inappropriate OACs prescription in AF patients and assesment of the number of&#xD;
      patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism&#xD;
      risk according to CHA2DS2-VASc score.&#xD;
&#xD;
      The POL-AF Registry is a multicenter prospective analysis of hospital records of patients&#xD;
      with AF managed in ten cardiology centers.&#xD;
&#xD;
      Collected data will include demographics, type of AF (valvular and non-valvular, as well as&#xD;
      paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic&#xD;
      parameters and concomitant medications.&#xD;
&#xD;
      Each patient will be evaluated regarding to common scales assessing risk of thromboembolic&#xD;
      (CHA2DS2-VASc) and bleeding (HAS-BLED, modifiable and non-modifiable risk factors for&#xD;
      bleeding in anticoagulated patients basing on the current guidelines for AF treatment)&#xD;
      events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 6, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.</measure>
    <time_frame>Through the study completion, an average of 2 months.</time_frame>
    <description>Compared data will include: frequency of VKAs vs NOACs prescriptions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.</measure>
    <time_frame>Through the study completion, an average of 2 months.</time_frame>
    <description>Compared data will include: demographics, type of AF, medical history, baseline characteristics and concomitant medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc (heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex) score.</measure>
    <time_frame>Through the study completion, an average of 2 months.</time_frame>
    <description>The CHA2DS2-VAS score includes the following factors: heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex.&#xD;
According to the CHA2DS2-VAS score, high thromboembolic risk means 2 points in men, 3 points in women.&#xD;
Data on the components of CHA2DS2-VASC are obtained from medical records.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Patients with AF treated with VKA</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with AF treated with NOAC</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation</intervention_name>
    <description>observation</description>
    <arm_group_label>Patients with AF treated with NOAC</arm_group_label>
    <arm_group_label>Patients with AF treated with VKA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with AF hospitalized in a participating center during study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients with AF hospitalized in a participating center during study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hospitalisation for atrial fibrillation ablation&#xD;
&#xD;
          -  death during hospitalization&#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>Iwona Gorczyca, Md,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Collegium Medicum, Jan Kochanowski University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Iwona Gorczyca</name>
      <address>
        <city>Kielce</city>
        <zip>25-525</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jan Kochanowski University</investigator_affiliation>
    <investigator_full_name>Iwona Gorczyca</investigator_full_name>
    <investigator_title>MD, PhD, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>anticoagulant treatment</keyword>
  <keyword>apixaban</keyword>
  <keyword>dabigatran</keyword>
  <keyword>rivaroxaban</keyword>
  <keyword>vitamin K antagonist</keyword>
  <keyword>stroke prevention</keyword>
  <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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04419012
org study id: 104/018
nct id: NCT04419012
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients
      with atrial fibrillation (AF).
Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular
      mortality. An important element of management of patients with AF is anticoagulation to
      prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) and vitamin K
      antagonists (VKAs) are two main drugs groups used in thromboembolic events prevention.

      Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF
      patients treatment of with OACs.

      Secondary objective of the study are as follows: assessment of the frequency of
      appropriate/inappropriate OACs prescription in AF patients and assesment of the number of
      patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism
      risk according to CHA2DS2-VASc score.

      The POL-AF Registry is a multicenter prospective analysis of hospital records of patients
      with AF managed in ten cardiology centers.

      Collected data will include demographics, type of AF (valvular and non-valvular, as well as
      paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic
      parameters and concomitant medications.

      Each patient will be evaluated regarding to common scales assessing risk of thromboembolic
      (CHA2DS2-VASc) and bleeding (HAS-BLED, modifiable and non-modifiable risk factors for
      bleeding in anticoagulated patients basing on the current guidelines for AF treatment)
      events.
observational model: Cohort
time perspective: Prospective
measure: Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.
time frame: Through the study completion, an average of 2 months.
description: Compared data will include: frequency of VKAs vs NOACs prescriptions.
measure: Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.
time frame: Through the study completion, an average of 2 months.
description: Compared data will include: demographics, type of AF, medical history, baseline characteristics and concomitant medications.
measure: Number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc (heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex) score.
time frame: Through the study completion, an average of 2 months.
description: The CHA2DS2-VAS score includes the following factors: heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex.
According to the CHA2DS2-VAS score, high thromboembolic risk means 2 points in men, 3 points in women.
Data on the components of CHA2DS2-VASC are obtained from medical records.
arm group label: Patients with AF treated with VKA
arm group label: Patients with AF treated with NOAC
intervention type: Other
intervention name: observation
description: observation
arm group label: Patients with AF treated with NOAC
arm group label: Patients with AF treated with VKA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Iwona Gorczyca, Md,PhD
role: Principal Investigator
affiliation: Collegium Medicum, Jan Kochanowski University
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Jan Kochanowski University
investigator full name: Iwona Gorczyca
investigator title: MD, PhD, Principal Investigator
mesh term: Atrial Fibrillation
sharing ipd: Undecided