<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/NCT04484688</url>
  </required_header>
  <id_info>
    <org_study_id>Prestilol</org_study_id>
    <nct_id>NCT04484688</nct_id>
  </id_info>
  <brief_title>Prestilol(Perindopril+Bisoprolol) in Therapy of Patients With Atrial Fibrilation</brief_title>
  <official_title>Perindopril+Bisoprolol in Therapy of Patients With Atrial Fibrilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aversi Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aversi Clinic</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>
      The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of&#xD;
      bisoprolol/perindopril in patients with permanent atrial fibrillation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>12-ecg and echocardiography evaluation after 1 month treatment</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Patient Participation</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>perindopril-bisoprolol</intervention_name>
    <description>outpatients with permanent atrial fibrillation and with preserved ejection fraction</description>
    <other_name>prestilol</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with AF and normal EF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:permanent atrial fibrillation with normal EF -&#xD;
&#xD;
        Exclusion Criteria:AF with decreased EF&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aversi Clinic</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
    <contact>
      <last_name>David Maisuradze</last_name>
      <phone>0995599950556</phone>
      <email>dvmaisuradze@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>David Maisuradze</last_name>
      <phone>0995599950556</phone>
      <email>dvmaisuyradze@hotmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Aversi Clinic</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
    <contact>
      <last_name>David Maisuradze, MD,FESC</last_name>
      <phone>0995599950556</phone>
      <email>dvmaisuradze@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Georgia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aversi Clinic</investigator_affiliation>
    <investigator_full_name>David Maisuradze</investigator_full_name>
    <investigator_title>MD,FESC</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bisoprolol</mesh_term>
    <mesh_term>Perindopril</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04484688
org study id: Prestilol
nct id: NCT04484688
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of
      bisoprolol/perindopril in patients with permanent atrial fibrillation
observational model: Case-Only
time perspective: Prospective
measure: 12-ecg and echocardiography evaluation after 1 month treatment
time frame: 1 month
intervention type: Drug
intervention name: perindopril-bisoprolol
description: outpatients with permanent atrial fibrillation and with preserved ejection fraction
other name: prestilol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
contact: 
contact backup: 
facility: 
contact: 
country: Georgia
responsible party type: Principal Investigator
investigator affiliation: Aversi Clinic
investigator full name: David Maisuradze
investigator title: MD,FESC
mesh term: Bisoprolol
mesh term: Perindopril
sharing ipd: Yes
ipd info type: Clinical Study Report (CSR)