<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/NCT02987062</url>
  </required_header>
  <id_info>
    <org_study_id>CRAFT</org_study_id>
    <nct_id>NCT02987062</nct_id>
  </id_info>
  <brief_title>MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT)</brief_title>
  <acronym>CRAFT</acronym>
  <official_title>CRAFT - Multicenter Experience in Atrial Fibrillation Patients Treated With OAC (CRAFT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to current guidelines for non-valvular atrial fibrillation treatment, the first&#xD;
      line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K&#xD;
      antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval&#xD;
      trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on&#xD;
      real-life clinical practice.&#xD;
&#xD;
      The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs)&#xD;
      in an academic and district hospital, with regard to inclusion/exclusion criteria used in the&#xD;
      clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular&#xD;
      morbidity and mortality. An integral element of management of patients with AF is&#xD;
      anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants and&#xD;
      vitamin K antagonists are two main drugs groups used in treatment.&#xD;
&#xD;
      Primary objective of the study is to assess the treatment of AF patients with OACs (the&#xD;
      frequency of prescription of VKAs vs NOACs), compare the clinical characteristics of the&#xD;
      real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF,&#xD;
      RE-LY and ARISTOTLE) and population gathered from the university department and the district&#xD;
      hospital. Secondary objective of the study is to assess the long-term outcomes of patients&#xD;
      with AF treated with OACs.&#xD;
&#xD;
      The CRAFT (MultiCenter expeRience in AFib patients Treated with OAC) is a multicenter&#xD;
      retrospective analysis of hospital records of patients with AF managed in the First&#xD;
      Department of Cardiology of Medical University of Warsaw and in John Paul II Western Hospital&#xD;
      in Grodzisk Mazowiecki. Gathered data will include demographics, type of AF (valvular and&#xD;
      non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline&#xD;
      characteristics (i.e. blood pressure), laboratory investigations (blood tests, including&#xD;
      renal and hepatic function), echocardiographic parameters and concomitant medications. Data&#xD;
      will be collected from the moment of patient's discharge.&#xD;
&#xD;
      Each patient will be evaluated regarding to common and new scales assessing risk of&#xD;
      thromboembolic (CHA2DS2-VASc ) and bleeding (HAS-BLED, HEMORR2HAGES, modifiable and&#xD;
      non-modifiable risk factors for bleeding in anticoagulated patients basing on the current&#xD;
      guidelines for AF treatment) events, as well as SAMeTT2R2 score to predict the quality of&#xD;
      treatment on OACs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)</measure>
    <time_frame>Through the study completion, an average of 3 months.</time_frame>
    <description>Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital</measure>
    <time_frame>Through the study completion, an average of 3 months.</time_frame>
    <description>Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.</description>
  </primary_outcome>
  <secondary_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 3 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)</measure>
    <time_frame>Through the study completion, an average of 3 months.</time_frame>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Acenocoumarol</arm_group_label>
    <description>Patients with AF treated with acenocoumarol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warfarin</arm_group_label>
    <description>Patients with AF treated with warfarin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apixaban</arm_group_label>
    <description>Patients with AF treated with apixaban.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dabigatran</arm_group_label>
    <description>Patients with AF treated with dabigatran.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>Patients with AF treated with rivaroxaban.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include patients with AF treated with VKAs (acenocoumarol, warfarin) and&#xD;
        NOACs (apixaban, dabigatran, riwaroxaban), hospitalized in 2011-2016 years in the First&#xD;
        Department of Cardiology of Medical University of Warsaw and hospitalized in 2014-2016 in&#xD;
        the John Paul II Western Hospital in Grodzisk Mazowiecki, Poland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  paroxysmal, persistent, long-standing persistent or permanent AF&#xD;
&#xD;
          -  valvular or non-valvular AF&#xD;
&#xD;
          -  treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  lack of OAC at hospital discharge&#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>Grzegorz Opolski, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>1st Department of Cardiology Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcin Grabowski, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>1st Department of Cardiology Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paweł Balsam, PhD</last_name>
    <phone>605 152 120</phone>
    <phone_ext>0048</phone_ext>
    <email>pawel.balsam@me.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Krzysztof Ozierański, MD</last_name>
    <phone>509 996 947</phone>
    <phone_ext>0048</phone_ext>
    <email>krzysztof.ozieranski@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>1st Department of Cardiology Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowiecki</state>
        <zip>02-097</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paweł Balsam, PhD</last_name>
      <phone>605 152 120</phone>
      <phone_ext>0048</phone_ext>
      <email>pawel.balsam@me.com</email>
    </contact>
    <contact_backup>
      <last_name>Krzysztof Ozierański, MD</last_name>
      <phone>509 996 947</phone>
      <phone_ext>0048</phone_ext>
      <email>krzysztof.ozieranski@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Paweł Balsam, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Krzysztof Ozierański, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Agata Tymińska, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michał Peller, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcin Grabowski, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Grzegorz Opolski, Professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katarzyna Żukowska, student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katarzyna Szepietowska, student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Martyna Zaleska, student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kacper Maciejewski, student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Paul II Western Hospital</name>
      <address>
        <city>Grodzisk Mazowiecki</city>
        <zip>05-825</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janusz Bednarski, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Janusz Bednarski, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>June 7, 2017</last_update_submitted>
  <last_update_submitted_qc>June 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Marcin Grabowski</investigator_full_name>
    <investigator_title>Clinical Professor, Marcin Grabowski, Medical University of Warsaw</investigator_title>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Non-vitamin K Oral Anticoagulants</keyword>
  <keyword>Vitamin K Antagonists</keyword>
  <keyword>ROCKET-AF</keyword>
  <keyword>RE-LY</keyword>
  <keyword>ARISTOTLE</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/NCT02987062
org study id: CRAFT
nct id: NCT02987062
lead sponsor: 
has dmc: No
According to current guidelines for non-valvular atrial fibrillation treatment, the first
      line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K
      antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval
      trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on
      real-life clinical practice.

      The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs)
      in an academic and district hospital, with regard to inclusion/exclusion criteria used in the
      clinical trials.
Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular
      morbidity and mortality. An integral element of management of patients with AF is
      anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants and
      vitamin K antagonists are two main drugs groups used in treatment.

      Primary objective of the study is to assess the treatment of AF patients with OACs (the
      frequency of prescription of VKAs vs NOACs), compare the clinical characteristics of the
      real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF,
      RE-LY and ARISTOTLE) and population gathered from the university department and the district
      hospital. Secondary objective of the study is to assess the long-term outcomes of patients
      with AF treated with OACs.

      The CRAFT (MultiCenter expeRience in AFib patients Treated with OAC) is a multicenter
      retrospective analysis of hospital records of patients with AF managed in the First
      Department of Cardiology of Medical University of Warsaw and in John Paul II Western Hospital
      in Grodzisk Mazowiecki. Gathered data will include demographics, type of AF (valvular and
      non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline
      characteristics (i.e. blood pressure), laboratory investigations (blood tests, including
      renal and hepatic function), echocardiographic parameters and concomitant medications. Data
      will be collected from the moment of patient's discharge.

      Each patient will be evaluated regarding to common and new scales assessing risk of
      thromboembolic (CHA2DS2-VASc ) and bleeding (HAS-BLED, HEMORR2HAGES, modifiable and
      non-modifiable risk factors for bleeding in anticoagulated patients basing on the current
      guidelines for AF treatment) events, as well as SAMeTT2R2 score to predict the quality of
      treatment on OACs.
observational model: Cohort
time perspective: Retrospective
measure: Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)
time frame: Through the study completion, an average of 3 months.
description: Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
measure: Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital
time frame: Through the study completion, an average of 3 months.
description: Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
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 3 months.
measure: Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)
time frame: Through the study completion, an average of 3 months.
arm group label: Acenocoumarol
description: Patients with AF treated with acenocoumarol.
arm group label: Warfarin
description: Patients with AF treated with warfarin.
arm group label: Apixaban
description: Patients with AF treated with apixaban.
arm group label: Dabigatran
description: Patients with AF treated with dabigatran.
arm group label: Rivaroxaban
description: Patients with AF treated with rivaroxaban.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Grzegorz Opolski, Professor
role: Study Chair
affiliation: 1st Department of Cardiology Medical University of Warsaw
last name: Marcin Grabowski, PhD
role: Study Chair
affiliation: 1st Department of Cardiology Medical University of Warsaw
last name: Paweł Balsam, PhD
phone: 605 152 120
phone ext: 0048
email: pawel.balsam@me.com
last name: Krzysztof Ozierański, MD
phone: 509 996 947
phone ext: 0048
email: krzysztof.ozieranski@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Marcin Grabowski
investigator title: Clinical Professor, Marcin Grabowski, Medical University of Warsaw
mesh term: Atrial Fibrillation