<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/NCT02219984</url>
  </required_header>
  <id_info>
    <org_study_id>142/2010/O/Oss</org_study_id>
    <nct_id>NCT02219984</nct_id>
  </id_info>
  <brief_title>START-Register: Survey on Anticoagulated Patients Register</brief_title>
  <official_title>Phase 4 Study on Clinical History of Patients Who Start a Chronic Anticoagulant Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GUALTIERO PALARETI</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arianna Anticoagulazione Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 4 cohort prospective, open, national, multicentre study that collects data on&#xD;
      history of patients treated chronically with anticoagulant drugs, including the novel direct&#xD;
      oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and&#xD;
      is not intended to have any influence on the treatment of the single patients included.&#xD;
&#xD;
      Patients are included when they start the anticoagulant treatment, whatever the drug used, or&#xD;
      when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral&#xD;
      anticoagulants, provided that the therapy is expected to last at least 3 months.&#xD;
&#xD;
      The general aims of the study are to provide a better evaluation of efficacy and safety of&#xD;
      different treatment options, and to improve our understanding of the risks/benefits of the&#xD;
      various anticoagulant drugs and the different therapy options.&#xD;
&#xD;
      The Registry is open to the participation of clinical centres or individual professionals&#xD;
      (now called Participants) that are involved with management of anticoagulated patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants can include patients with 18 years or more who satisfy the following preset&#xD;
      criteria:&#xD;
&#xD;
        -  Participants should included patients consecutively to avoid selection bias; criteria to&#xD;
           avoid selection bias are proposed to Participants, which should decide the one they want&#xD;
           to adopt.&#xD;
&#xD;
        -  Patients should have been receiving anticoagulation therapy for no more than 30 days at&#xD;
           the time of inclusion, regardless of age, clinical indication for treatment, therapeutic&#xD;
           range expected (in cases of treatment with VKAs) and expected duration of the treatment&#xD;
           (providing a duration of at least 3 months is foreseen). Patients who have already been&#xD;
           receiving chronic anticoagulation therapy for some time may be included if they are&#xD;
           switched from VKAs to DOACs or to low molecular weight heparin or to fondaparinux&#xD;
&#xD;
        -  Patients not prepared to undergo constant monitoring at their enrolling centres or who&#xD;
           take part in phase II or III clinical studies should not be included. Patients who&#xD;
           participate in other observational or phase IV studies can be included in the Register.&#xD;
&#xD;
        -  All patients must give their informed written consent -- following procedures laid down&#xD;
           by local Ethical Committees - for the compilation and conservation on the Register's&#xD;
           central database of data regarding their personal clinical histories and anticoagulation&#xD;
           treatment patterns and for use of said data.&#xD;
&#xD;
        -  All the patients inserted must be followed for at least 1 year, even though an&#xD;
           indefinite follow-up of all patients continuing anticoagulation therapy is highly&#xD;
           recommended. If in single patients anticoagulation treatment is discontinued within 1&#xD;
           year of inclusion, active participating members should nonetheless keep on compiling&#xD;
           (telephonically too) information regarding the possible onset of complications&#xD;
           (thrombotic, bleeding clinical events of another nature) till 1 year -follow-up.&#xD;
&#xD;
        -  The Participants of the Register must use a computer programme as database - for all the&#xD;
           information to be collected. The computer programme must meet the features requested by&#xD;
           the Executive Committee of the Registry and must be able to send the information to the&#xD;
           centralised database via internet and connection to the web site. By way of alternative&#xD;
           the Participants can use the &quot;Simple-START&quot; software provided free by the Registry.&#xD;
&#xD;
        -  As criterion for safeguarding the privacy of patients, every patient inserted in the&#xD;
           Registry is identified by a &quot;Patient log&quot; which includes the identification code of the&#xD;
           enrolling Participant and the identification code of each single patient, using the&#xD;
           computer database programme used by the Participant. The enrolling Participant is&#xD;
           committed to keeping for the whole duration of the Register the whole demographic data&#xD;
           of each patient associated with the Patient log&quot;.&#xD;
&#xD;
        -  Are excluded patients who: have &lt; 18 years age, are not willing to sign informed&#xD;
           consent, are not ready to submit to constant monitoring, participate in phase II or III&#xD;
           clinical studies&#xD;
&#xD;
        -  Follow-Up All the patients inserted must be followed for at least 1 year even though an&#xD;
           indefinite follow up of all patients continuing anticoagulation therapy is strongly&#xD;
           recommended. If anticoagulation therapy is interrupted in single patients within 1 year&#xD;
           of insertion the Participants must still continue to collect (even telephonically) data&#xD;
           regarding the possible onset of complications (thrombotic, bleeding or other clinical&#xD;
           events) for 1 year of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2011</start_date>
  <completion_date type="Anticipated">November 2027</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>incidence of complications (number per cent patient-years of treatment)</measure>
    <time_frame>at 1 year of follow-up</time_frame>
    <description>from date of inclusion in the registry until the date of first documented major complication or date of death from any cause, whichever came first, assessed up to 5 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time in the therapeutic range (TTR)</measure>
    <time_frame>at 1 year</time_frame>
    <description>This only applies to patients who receive VKAs for treatment; from date of inclusion in the registry until the date of VKA treatment was stopped, or date of death from any cause, whichever came first, assessed up to 5 years</description>
  </secondary_outcome>
  <other_outcome>
    <measure>percentage of patients who stop anticoagulant treatment</measure>
    <time_frame>at 1 year</time_frame>
    <description>This applies only to patients anticoagulated for atrial fibrillation; from date of inclusion in the registry until the date anticoagulant treatment was discontinued, or date of death from any cause, whichever came first, assessed up to 5 years</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15410</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Venous Thromboembolism</condition>
  <condition>Heart Valve Diseases or Prosthesis</condition>
  <arm_group>
    <arm_group_label>patients anticoagulated</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anticoagulants</intervention_name>
    <arm_group_label>patients anticoagulated</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma samples for measurements of anticoagulant drug activity&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Are included in the Registry patients who need chronic anticoagulation for atrial&#xD;
        fibrillation, or venous thromboembolism, or heart valve diseases or prosthesis, or other&#xD;
        clinical conditions requiring anticoagulation.&#xD;
&#xD;
        For the sampling method, participants are instructed to choose and declare one modality of&#xD;
        inclusion for VKA treated patients: one week per month, or one day per week (always the&#xD;
        same), etc. For patients treated with DOACs (low number in our country) it is recommended&#xD;
        to include all patients progressively&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;= 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years&#xD;
&#xD;
          -  not willing to sign informed consent&#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_contact>
    <last_name>Gualtiero Palareti, MD</last_name>
    <phone>+ 328 2279868</phone>
    <email>gualtiero.palareti@unibo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>S. Orsola-Malpighi University hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emilia Antonucci</last_name>
      <phone>+39 051 4291116</phone>
      <email>e.antonucci@fondazionearianna.org</email>
    </contact>
    <investigator>
      <last_name>Benilde Cosmi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>GUALTIERO PALARETI</investigator_full_name>
    <investigator_title>Professor in Vascular Medicine</investigator_title>
  </responsible_party>
  <keyword>Anticoagulation</keyword>
  <keyword>vitamin K antagonists</keyword>
  <keyword>Warfarin</keyword>
  <keyword>low molecular weight heparin</keyword>
  <keyword>fondaparinux</keyword>
  <keyword>antithrombotics</keyword>
  <keyword>Direct oral anticoagulants</keyword>
  <keyword>dabigatran</keyword>
  <keyword>rivaroxaban</keyword>
  <keyword>apixaban</keyword>
  <keyword>edoxaban</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>venous thromboembolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219984
org study id: 142/2010/O/Oss
nct id: NCT02219984
lead sponsor: 
collaborator: 
has dmc: Yes
This is a phase 4 cohort prospective, open, national, multicentre study that collects data on
      history of patients treated chronically with anticoagulant drugs, including the novel direct
      oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and
      is not intended to have any influence on the treatment of the single patients included.

      Patients are included when they start the anticoagulant treatment, whatever the drug used, or
      when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral
      anticoagulants, provided that the therapy is expected to last at least 3 months.

      The general aims of the study are to provide a better evaluation of efficacy and safety of
      different treatment options, and to improve our understanding of the risks/benefits of the
      various anticoagulant drugs and the different therapy options.

      The Registry is open to the participation of clinical centres or individual professionals
      (now called Participants) that are involved with management of anticoagulated patients.
Participants can include patients with 18 years or more who satisfy the following preset
      criteria:

        -  Participants should included patients consecutively to avoid selection bias; criteria to
           avoid selection bias are proposed to Participants, which should decide the one they want
           to adopt.

        -  Patients should have been receiving anticoagulation therapy for no more than 30 days at
           the time of inclusion, regardless of age, clinical indication for treatment, therapeutic
           range expected (in cases of treatment with VKAs) and expected duration of the treatment
           (providing a duration of at least 3 months is foreseen). Patients who have already been
           receiving chronic anticoagulation therapy for some time may be included if they are
           switched from VKAs to DOACs or to low molecular weight heparin or to fondaparinux

        -  Patients not prepared to undergo constant monitoring at their enrolling centres or who
           take part in phase II or III clinical studies should not be included. Patients who
           participate in other observational or phase IV studies can be included in the Register.

        -  All patients must give their informed written consent -- following procedures laid down
           by local Ethical Committees - for the compilation and conservation on the Register's
           central database of data regarding their personal clinical histories and anticoagulation
           treatment patterns and for use of said data.

        -  All the patients inserted must be followed for at least 1 year, even though an
           indefinite follow-up of all patients continuing anticoagulation therapy is highly
           recommended. If in single patients anticoagulation treatment is discontinued within 1
           year of inclusion, active participating members should nonetheless keep on compiling
           (telephonically too) information regarding the possible onset of complications
           (thrombotic, bleeding clinical events of another nature) till 1 year -follow-up.

        -  The Participants of the Register must use a computer programme as database - for all the
           information to be collected. The computer programme must meet the features requested by
           the Executive Committee of the Registry and must be able to send the information to the
           centralised database via internet and connection to the web site. By way of alternative
           the Participants can use the "Simple-START" software provided free by the Registry.

        -  As criterion for safeguarding the privacy of patients, every patient inserted in the
           Registry is identified by a "Patient log" which includes the identification code of the
           enrolling Participant and the identification code of each single patient, using the
           computer database programme used by the Participant. The enrolling Participant is
           committed to keeping for the whole duration of the Register the whole demographic data
           of each patient associated with the Patient log".

        -  Are excluded patients who: have < 18 years age, are not willing to sign informed
           consent, are not ready to submit to constant monitoring, participate in phase II or III
           clinical studies

        -  Follow-Up All the patients inserted must be followed for at least 1 year even though an
           indefinite follow up of all patients continuing anticoagulation therapy is strongly
           recommended. If anticoagulation therapy is interrupted in single patients within 1 year
           of insertion the Participants must still continue to collect (even telephonically) data
           regarding the possible onset of complications (thrombotic, bleeding or other clinical
           events) for 1 year of follow-up.
observational model: Cohort
time perspective: Prospective
measure: incidence of complications (number per cent patient-years of treatment)
time frame: at 1 year of follow-up
description: from date of inclusion in the registry until the date of first documented major complication or date of death from any cause, whichever came first, assessed up to 5 years.
measure: Percentage of Time in the therapeutic range (TTR)
time frame: at 1 year
description: This only applies to patients who receive VKAs for treatment; from date of inclusion in the registry until the date of VKA treatment was stopped, or date of death from any cause, whichever came first, assessed up to 5 years
measure: percentage of patients who stop anticoagulant treatment
time frame: at 1 year
description: This applies only to patients anticoagulated for atrial fibrillation; from date of inclusion in the registry until the date anticoagulant treatment was discontinued, or date of death from any cause, whichever came first, assessed up to 5 years
arm group label: patients anticoagulated
intervention type: Drug
intervention name: Anticoagulants
arm group label: patients anticoagulated
plasma samples for measurements of anticoagulant drug activity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gualtiero Palareti, MD
phone: + 328 2279868
email: gualtiero.palareti@unibo.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: GUALTIERO PALARETI
investigator title: Professor in Vascular Medicine
mesh term: Atrial Fibrillation
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Heart Valve Diseases
mesh term: Anticoagulants
sharing ipd: Undecided