<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/NCT03790917</url>
  </required_header>
  <id_info>
    <org_study_id>ANTEY</org_study_id>
    <nct_id>NCT03790917</nct_id>
  </id_info>
  <brief_title>Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY</brief_title>
  <acronym>ANTEY</acronym>
  <official_title>Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Center for Preventive Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Medical Research Center for Therapy and Preventive Medicine</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>
      A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF&#xD;
      patients using the validated adherence Scale.&#xD;
&#xD;
      Primary Study Objective(s) Primary study objective The aim of the present study is to assess&#xD;
      adherence to therapy and factors associated with adherence in patients with CV disease&#xD;
      complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient&#xD;
      registry PROFILE (prospective, observational study).&#xD;
&#xD;
        1. Data collection in patients with non-valvular atrial fibrillation requiring OAC&#xD;
           treatment included in the registry&#xD;
&#xD;
        2. Evaluation of actual patient adherence to OACs&#xD;
&#xD;
      Secondary Study Objective(s)&#xD;
&#xD;
        1. Evaluation of potential patient adherence to OACs&#xD;
&#xD;
        2. Determination of the most significant factors associated with adherence to OACs in&#xD;
           patients with non-valvular AF&#xD;
&#xD;
        3. Validation of new original 5-item Questionnaire&#xD;
&#xD;
        4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC).&#xD;
           Management of atrial fibrillation,2016)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AF patients from ongoing PROFILE registry will be invited to visit the scientific center.&#xD;
&#xD;
      2 visits with a 6-month interval are expected for each patient as part of routine clinical&#xD;
      practice and phone contact is scheduled for each patient 1 year from the first visit to the&#xD;
      scientific center (follow-up period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)</measure>
    <time_frame>6 months</time_frame>
    <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.&#xD;
Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)</measure>
    <time_frame>1 year</time_frame>
    <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.&#xD;
Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.&#xD;
Out of 201 participants of the study 4 patients died and 197 patients completed the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Potentially Adherent Patients</measure>
    <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
    <description>Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of OACs Prescribed by Doctors According to Guidelines</measure>
    <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
    <description>Prescription of OACs according to guidelines was considered &quot;positive&quot; if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation.&#xD;
Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more.&#xD;
Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more.&#xD;
Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk.&#xD;
NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C).&#xD;
In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Main Reasons for Refusing to Start NOAC Therapy</measure>
    <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
    <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for Stopping Oral Anticoagulants (Data From Visit 1)</measure>
    <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))</time_frame>
    <description>The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)</measure>
    <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
    <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.</description>
  </secondary_outcome>
  <enrollment type="Actual">201</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary patients with non-valvular atrial fibrillation included in the outpatient registry&#xD;
        PROFILE during the period 01.01.2011-31.08.2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women above 18 years of age who were included in the PROFILE registry by the&#xD;
             start of the observational study&#xD;
&#xD;
          -  Presence of written informed consent to participate in the study, fill in the study&#xD;
             questionnaires and have personal data analyzed&#xD;
&#xD;
          -  Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1&#xD;
             or patients with CHA2DS2-VASc score = 0, who are already taking OAK&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with high bleeding risk, including patients with:&#xD;
&#xD;
               -  Congenital or acquired bleeding disorders&#xD;
&#xD;
               -  Uncontrolled resistant hypertension&#xD;
&#xD;
               -  Exacerbation of gastric and duodenal ulcer&#xD;
&#xD;
               -  Vascular retinopathy&#xD;
&#xD;
               -  Recent history of intracranial or intracerebral hemorrhage&#xD;
&#xD;
               -  Pathology of the brain and spinal cord vessels&#xD;
&#xD;
               -  Recent history of brain, spinal cord or eye surgery&#xD;
&#xD;
               -  History of bronchiectasis or pulmonary hemorrhage&#xD;
&#xD;
               -  A CHA2DS2-VASc score of 0 (OACs are not indicated)&#xD;
&#xD;
               -  Pregnancy, lactation&#xD;
&#xD;
               -  Planned surgery&#xD;
&#xD;
               -  Known hypersensitivity to ingredients of medications used in the study&#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>Sergey Martsevich, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Research Center of Preventive Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Research Center for Preventive Medicine</name>
      <address>
        <city>Moscow</city>
        <zip>101990</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <results_first_submitted>January 10, 2020</results_first_submitted>
  <results_first_submitted_qc>May 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adherence</keyword>
  <keyword>new oral anticoagulants (NOACs)</keyword>
  <keyword>AF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03790917/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ANTEY</title>
          <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="201"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ANTEY</title>
          <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="201"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.1" spread="8.7"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NOAC recommended to patients by doctors during V0</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>rivaroxaban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dabigatran</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>apixaban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)</title>
        <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.&#xD;
Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)</title>
          <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.&#xD;
Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>completely adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                  </measurement_list>
                </category>
                <category>
                  <title>partially adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>partially non-adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>completely non-adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)</title>
        <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.&#xD;
Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.&#xD;
Out of 201 participants of the study 4 patients died and 197 patients completed the study.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)</title>
          <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.&#xD;
Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.&#xD;
Out of 201 participants of the study 4 patients died and 197 patients completed the study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>completely adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>partially adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>partially non-adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>completely non-adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Potentially Adherent Patients</title>
        <description>Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.</description>
        <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Potentially Adherent Patients</title>
          <description>Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>completely adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>partially adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>completely non-adherent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of OACs Prescribed by Doctors According to Guidelines</title>
        <description>Prescription of OACs according to guidelines was considered &quot;positive&quot; if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation.&#xD;
Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more.&#xD;
Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more.&#xD;
Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk.&#xD;
NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C).&#xD;
In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.</description>
        <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of OACs Prescribed by Doctors According to Guidelines</title>
          <description>Prescription of OACs according to guidelines was considered &quot;positive&quot; if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation.&#xD;
Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more.&#xD;
Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more.&#xD;
Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk.&#xD;
NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C).&#xD;
In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>OACs were recommended by doctors</title>
                  <measurement_list>
                    <measurement group_id="O1" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>OACs were not recommended by doctors</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Main Reasons for Refusing to Start NOAC Therapy</title>
        <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.</description>
        <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>The Main Reasons for Refusing to Start NOAC Therapy</title>
          <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>high price of NOAC</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>fear of adverse events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>doubts about the correctness of prescribtion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>adherence to Warfarin</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>adherence to another NOAC</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>difficult regimen for all drugs</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>lack of NOAC in the preferential drug list</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reasons for Stopping Oral Anticoagulants (Data From Visit 1)</title>
        <description>The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).</description>
        <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Reasons for Stopping Oral Anticoagulants (Data From Visit 1)</title>
          <description>The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>bleeding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>cancellation by another doctor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>high cost</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)</title>
        <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.</description>
        <time_frame>Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ANTEY</title>
            <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
          </group>
        </group_list>
        <measure>
          <title>Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)</title>
          <description>The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>bleeding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>cancellation by another doctor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>high cost</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>others</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.</desc>
      <group_list>
        <group group_id="E1">
          <title>ANTEY</title>
          <description>Patients with AF from the &quot;PROFILE&quot; registry were included. The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="4" subjects_at_risk="201"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <description>Severe iron deficiency anaemia, emergency hospitalization</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myiocardial infarction</sub_title>
                <description>Non-fatal AMI</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
              <event>
                <sub_title>Unstable angina pectoris</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="201"/>
              </event>
              <event>
                <sub_title>CHF decompensation</sub_title>
                <description>Hospitalization due to CHF decompensation</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="201"/>
              </event>
              <event>
                <sub_title>Paroxysm of atrial fibrillation</sub_title>
                <description>Paroxysm of atrial fibrillation, emergency hospitalization</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding in the retina</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>Bleeding in the retina, emergency hospitalization</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Sarcoma</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <description>amiodarone-induced hypothyroidism</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="201"/>
              </event>
              <event>
                <sub_title>Obstipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>Bleeding of different localization due to NOAC therapy, non-severe</description>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Gynecomastia</sub_title>
                <description>Spironolactone-induced gynecomastia</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="201"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>professor Sergey Yu. Martsevich</name_or_title>
      <organization>National Medical Research Center for Preventive Medicine</organization>
      <phone>89161643690</phone>
      <email>sergeymartsevich@mail.ru</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/NCT03790917
org study id: ANTEY
nct id: NCT03790917
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF
      patients using the validated adherence Scale.

      Primary Study Objective(s) Primary study objective The aim of the present study is to assess
      adherence to therapy and factors associated with adherence in patients with CV disease
      complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient
      registry PROFILE (prospective, observational study).

        1. Data collection in patients with non-valvular atrial fibrillation requiring OAC
           treatment included in the registry

        2. Evaluation of actual patient adherence to OACs

      Secondary Study Objective(s)

        1. Evaluation of potential patient adherence to OACs

        2. Determination of the most significant factors associated with adherence to OACs in
           patients with non-valvular AF

        3. Validation of new original 5-item Questionnaire

        4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC).
           Management of atrial fibrillation,2016)
AF patients from ongoing PROFILE registry will be invited to visit the scientific center.

      2 visits with a 6-month interval are expected for each patient as part of routine clinical
      practice and phone contact is scheduled for each patient 1 year from the first visit to the
      scientific center (follow-up period).
observational model: Cohort
time perspective: Prospective
measure: Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
time frame: 6 months
description: The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.
Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.
measure: Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
time frame: 1 year
description: The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs.
Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.
Out of 201 participants of the study 4 patients died and 197 patients completed the study.
measure: Proportion of Potentially Adherent Patients
time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
description: Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.
measure: Proportion of OACs Prescribed by Doctors According to Guidelines
time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
description: Prescription of OACs according to guidelines was considered "positive" if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation.
Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more.
Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more.
Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk.
NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C).
In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.
measure: The Main Reasons for Refusing to Start NOAC Therapy
time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
description: The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.
measure: Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
description: The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).
measure: Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
description: The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergey Martsevich, MD,PhD
role: Principal Investigator
affiliation: National Research Center of Preventive Medicine
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Atrial Fibrillation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 