<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/NCT03760874</url>
  </required_header>
  <id_info>
    <org_study_id>19062013</org_study_id>
    <nct_id>NCT03760874</nct_id>
  </id_info>
  <brief_title>Atrial Fibrillation Research Database</brief_title>
  <official_title>Prospective Register Study to Record Safety and Efficacy of Oral Anticoagulants in Atrial Fibrillation Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Monaldi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      All patients with atrial fibrillation who are treated with vitamin-k antagonists (warfarin,&#xD;
      phenprocoumon) or non vitamin K oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban,&#xD;
      Edoxaban) in real world settings will be recorded in this register. Within this register a&#xD;
      characterization of patients and therapy (with regard to medication, dose and duration) will&#xD;
      be done. On basis of defined clinical relevant end points the long-term efficacy and safety&#xD;
      will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 13, 2013</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>5 Years</target_duration>
  <primary_outcome>
    <measure>Thromboembolic Events</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding Events</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Anticoagulants and Bleeding Disorders</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Non Vitamin K Oral Anticoagulant</arm_group_label>
    <description>Dabigatran, Rivaroxaban, Apixaban, Edoxaban</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin K Oral Anticoagulant</arm_group_label>
    <description>Warfarin, Acenocoumarol.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with atrial fibrillation in clinical practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with atrial fibrillation&#xD;
&#xD;
          -  Indication for oral anticoagulant treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing Informed Consent Form&#xD;
&#xD;
          -  Missing Contact Informations for Follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Campania &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincenzo Russo</last_name>
      <email>vincenzo.russo@unicampania.it</email>
    </contact>
    <investigator>
      <last_name>Vincenzo Russo, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Vincenzo Russo</investigator_full_name>
    <investigator_title>MD, PhD, Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03760874
org study id: 19062013
nct id: NCT03760874
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
All patients with atrial fibrillation who are treated with vitamin-k antagonists (warfarin,
      phenprocoumon) or non vitamin K oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban,
      Edoxaban) in real world settings will be recorded in this register. Within this register a
      characterization of patients and therapy (with regard to medication, dose and duration) will
      be done. On basis of defined clinical relevant end points the long-term efficacy and safety
      will be evaluated.
observational model: Cohort
time perspective: Prospective
measure: Thromboembolic Events
time frame: 1 year
measure: Bleeding Events
time frame: 1 year
arm group label: Non Vitamin K Oral Anticoagulant
description: Dabigatran, Rivaroxaban, Apixaban, Edoxaban
arm group label: Vitamin K Oral Anticoagulant
description: Warfarin, Acenocoumarol.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Vincenzo Russo
investigator title: MD, PhD, Assistant Professor
mesh term: Atrial Fibrillation
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: No