<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/NCT02222090</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-14-1181-IG-CTIL</org_study_id>
    <nct_id>NCT02222090</nct_id>
  </id_info>
  <brief_title>Therapy With New Oral Anticoagulants</brief_title>
  <official_title>Therapy With New Oral Anticoagulants in Patients With Atrial Fibrillation and Renal Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present registry is to characterize and follow patients prospectively and&#xD;
      retrospectively with renal impairment who have been prescribed apixaban for the prevention of&#xD;
      stroke in atrial fibrillation, with a comparison to the characteristics and outcomes&#xD;
      associated with warfarin therapy in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current guidelines for the management of patients with atrial fibrillation (AF) recommend the&#xD;
      use of novel oral anticoagulants (NOACs) in patients with non-valvular AF .Renal dysfunction&#xD;
      has been shown to be an independent predictor of stroke or systemic emboli, but the risk of&#xD;
      bleeding with conventional warfarin therapy is also significantly increased.Prevalence of&#xD;
      renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of&#xD;
      patients having an estimated glomerular filtration rate (eGFR) of ≤ 60 ml/min/BSA [6].NOACs&#xD;
      undergoing significant renal secretion such as dabigatran are not recommended for patients&#xD;
      with severe renal impairment, and dose adjustment are indicated for patients with milder&#xD;
      degrees of renal dysfunction.However, real-world information regarding the usage and outcomes&#xD;
      associated with NOAC therapy in patients with renal dysfunction are limited. The&#xD;
      investigators plan to prospectively and retrospectively collect data regarding the clinical&#xD;
      settings, characteristics, and outcomes of patients with renal dysfunction who have been&#xD;
      prescribed apixaban in Israel, using a multicenter secure web-based registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Clinical Outcomes</measure>
    <time_frame>within 12 month from enrollment</time_frame>
    <description>To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>one-year outcomes</measure>
    <time_frame>within 12 month from enrollment</time_frame>
    <description>Establish the one-year outcomes of this patient population</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Non-valvular Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>patients who have been prescribed warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients who have been prescribed apixaba</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients prospectively and retropectively with renal impairment who have been prescribed&#xD;
        apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the&#xD;
        characteristics and outcomes associated with warfarin therapy in this population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with renal dysfunction (eGFR &lt;60 ml\min\BSA) who have an indication for&#xD;
             treatment with an novel oral anticoagulant agent or VKA&#xD;
&#xD;
          -  Patients prescribed apixaban or warfarin at the enrollment center (patients enrolled&#xD;
             in a 2:1 ratio)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Valvular AF or presence prosthetic valve&#xD;
&#xD;
          -  Dialysis patients&#xD;
&#xD;
          -  Contraindications NOACs&#xD;
&#xD;
          -  Hepatic dysfunction&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Clinical necessity to continue administration of potent inhibitors of both CYP3A4 and&#xD;
             P-gp - including azole- antimycotics (e.g. ketoconazole, itraconazole) and HIV&#xD;
             protease inhibitors (e.g. ritonavir)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilan Goldenberg, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alon Barsheshet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>beilinson Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Avishay Elias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>beilinson Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shmuel Fuchs, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>beilinson Medical center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KIRILL BUTURLIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moshe Swissa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaplan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ilan Goldenberg, Prof</last_name>
    <email>Ilan.Goldenberg@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262179</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ilan Goldenberg, MD</last_name>
      <phone>972-5302848</phone>
      <email>ilan.goldenberg@sheba.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Ilan Goldenberg, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02222090
org study id: SHEBA-14-1181-IG-CTIL
nct id: NCT02222090
lead sponsor: 
has dmc: No
The aim of the present registry is to characterize and follow patients prospectively and
      retrospectively with renal impairment who have been prescribed apixaban for the prevention of
      stroke in atrial fibrillation, with a comparison to the characteristics and outcomes
      associated with warfarin therapy in this population.
Current guidelines for the management of patients with atrial fibrillation (AF) recommend the
      use of novel oral anticoagulants (NOACs) in patients with non-valvular AF .Renal dysfunction
      has been shown to be an independent predictor of stroke or systemic emboli, but the risk of
      bleeding with conventional warfarin therapy is also significantly increased.Prevalence of
      renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of
      patients having an estimated glomerular filtration rate (eGFR) of ≤ 60 ml/min/BSA [6].NOACs
      undergoing significant renal secretion such as dabigatran are not recommended for patients
      with severe renal impairment, and dose adjustment are indicated for patients with milder
      degrees of renal dysfunction.However, real-world information regarding the usage and outcomes
      associated with NOAC therapy in patients with renal dysfunction are limited. The
      investigators plan to prospectively and retrospectively collect data regarding the clinical
      settings, characteristics, and outcomes of patients with renal dysfunction who have been
      prescribed apixaban in Israel, using a multicenter secure web-based registry.
observational model: Cohort
time perspective: Prospective
measure: Clinical Outcomes
time frame: within 12 month from enrollment
description: To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.
measure: one-year outcomes
time frame: within 12 month from enrollment
description: Establish the one-year outcomes of this patient population
arm group label: patients who have been prescribed warfarin
arm group label: patients who have been prescribed apixaba
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Ilan Goldenberg, Prof
role: Study Director
affiliation: Sheba Medical Center
last name: Alon Barsheshet, MD
role: Principal Investigator
affiliation: beilinson Medical Center
last name: Avishay Elias, MD
role: Principal Investigator
affiliation: beilinson Medical Center
last name: Shmuel Fuchs, Prof
role: Principal Investigator
affiliation: beilinson Medical center
last name: KIRILL BUTURLIN, MD
role: Principal Investigator
affiliation: Meir Medical Center
last name: Moshe Swissa, MD
role: Principal Investigator
affiliation: Kaplan Medical Center
last name: Ilan Goldenberg, Prof
email: Ilan.Goldenberg@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Atrial Fibrillation