<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/NCT03271450</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000215</org_study_id>
    <nct_id>NCT03271450</nct_id>
  </id_info>
  <brief_title>The DARE Warfarin CER Study</brief_title>
  <official_title>The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</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>
      Approximately half a million Americans annually experience venous thromboembolic disease,&#xD;
      including deep venous thrombosis (DVT) and pulmonary embolism (PE). Since 2010, four new oral&#xD;
      anticoagulants have been approved for marketing in addition to the vitamin K antagonist&#xD;
      warfarin. Very limited head-to-head data exists comparing these treatment options, leaving&#xD;
      patients, clinicians, and other stakeholders with little guidance for selecting the best&#xD;
      strategy that balances recurrence reduction with risk of bleeding. In the DARE Warfarin CER&#xD;
      Study, the researchers compare all five currently available oral anticoagulant agents for the&#xD;
      extended treatment of DVT and PE, as well as no extended treatment. This study also aims to&#xD;
      evaluate whether treatment heterogeneity exists for specific populations, such as older&#xD;
      patients or those with renal dysfunction. In a secondary aim, the study will also leverage a&#xD;
      database of linked electronic health record-insurance claims to validate diagnosis&#xD;
      definitions and account for potential residual confounding by factors unmeasured in claims&#xD;
      data. As the patient population includes all Medicare novel anticoagulant users and large&#xD;
      numbers of commercially insured and Medicaid patients, the results will likely be&#xD;
      transportable to the majority of US patients experiencing a DVT or PE. Pursuant to the&#xD;
      objectives of the Patient-Centered Outcomes Research Institute, a study advisory committee&#xD;
      consisting of key stakeholders will be actively involved in the study design and&#xD;
      dissemination of results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">October 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Safety Outcome: Intracranial bleed, Gastrointestinal bleed, Other Major bleed</measure>
    <time_frame>1-2 Years</time_frame>
    <description>Defined as a new episode of either Intracranial bleed, Gastrointestinal bleed or another Major bleed event during follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Effectiveness Outcome: Deep Venous Thrombosis, Pulmonary Embolism</measure>
    <time_frame>1-2 Years</time_frame>
    <description>Defined as a new episode of either Deep Venous Thrombosis or Pulmonary Embolism during follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>1-2 Years</time_frame>
    <description>Measured after index prescription date + 90 days and on date on which the event occurred and defined as hospitalization with discharge status code of: 20, 22-29, 40-42</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite safety and effectiveness outcome</measure>
    <time_frame>1-2 years</time_frame>
    <description>defined as earlier of safety or DVT/PE outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite safety and effectiveness outcome, including death</measure>
    <time_frame>1-2 years</time_frame>
    <description>Measured after index prescription date + 90 days and on date on which the event occurred and defined as hospitalization with discharge status code of: 20, 22-29, 40-42</description>
  </primary_outcome>
  <number_of_groups>30</number_of_groups>
  <enrollment type="Anticipated">416000</enrollment>
  <condition>Deep Venous Thrombosis</condition>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Continuer at 90 Days: Dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 180 Days: Dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 270 Days: Dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 90 Days: Apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 180 Days: Apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 270 Days: Apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 90 Days: Rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 180 Days: Rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 270 Days: Rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 90 Days: Edoxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 180 Days: Edoxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 270 Days: Edoxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 90 Days: Warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 180 Days: Warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuer at 270 Days: Warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 90 Days: Dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 180 Days: Dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 270 Days: Dabigatran</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 90 Days: Apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 180 Days: Apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 270 Days: Apixaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 90 Days: Rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 180 Days: Rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 270 Days: Rivaroxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 90 Days: Edoxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 180 Days: Edoxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 270 Days: Edoxaban</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 90 Days: Warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 180 Days: Warfarin</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuer at 270 Days: Warfarin</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran: extended treatment (e.g at least 90 days)</intervention_name>
    <description>90 days</description>
    <arm_group_label>Continuer at 90 Days: Dabigatran</arm_group_label>
    <arm_group_label>Discontinuer at 90 Days: Dabigatran</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran: extended treatment (e.g at least 180 days)</intervention_name>
    <description>180 days</description>
    <arm_group_label>Continuer at 180 Days: Dabigatran</arm_group_label>
    <arm_group_label>Discontinuer at 180 Days: Dabigatran</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran: extended treatment (e.g at least 270 days)</intervention_name>
    <description>270 days</description>
    <arm_group_label>Continuer at 270 Days: Dabigatran</arm_group_label>
    <arm_group_label>Discontinuer at 270 Days: Dabigatran</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban: extended treatment (e.g at least 90 days)</intervention_name>
    <description>90 days</description>
    <arm_group_label>Continuer at 90 Days: Apixaban</arm_group_label>
    <arm_group_label>Discontinuer at 90 Days: Apixaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban: extended treatment (e.g at least 180 days)</intervention_name>
    <description>180 days</description>
    <arm_group_label>Continuer at 180 Days: Apixaban</arm_group_label>
    <arm_group_label>Discontinuer at 180 Days: Apixaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban: extended treatment (e.g at least 270 days)</intervention_name>
    <description>270 days</description>
    <arm_group_label>Continuer at 270 Days: Apixaban</arm_group_label>
    <arm_group_label>Discontinuer at 270 Days: Apixaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban: extended treatment (e.g at least 90 days)</intervention_name>
    <description>90 days</description>
    <arm_group_label>Continuer at 90 Days: Rivaroxaban</arm_group_label>
    <arm_group_label>Discontinuer at 90 Days: Rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban: extended treatment (e.g at least 180 days)</intervention_name>
    <description>180 days</description>
    <arm_group_label>Continuer at 180 Days: Rivaroxaban</arm_group_label>
    <arm_group_label>Discontinuer at 180 Days: Rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban: extended treatment (e.g at least 270 days)</intervention_name>
    <description>270 days</description>
    <arm_group_label>Continuer at 270 Days: Rivaroxaban</arm_group_label>
    <arm_group_label>Discontinuer at 270 Days: Rivaroxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Edoxaban: extended treatment (e.g at least 90 days)</intervention_name>
    <description>90 days</description>
    <arm_group_label>Continuer at 90 Days: Edoxaban</arm_group_label>
    <arm_group_label>Discontinuer at 90 Days: Edoxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Edoxaban: extended treatment (e.g at least 180 days)</intervention_name>
    <description>180 days</description>
    <arm_group_label>Continuer at 180 Days: Edoxaban</arm_group_label>
    <arm_group_label>Discontinuer at 180 Days: Edoxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Edoxaban: extended treatment (e.g at least 270 days)</intervention_name>
    <description>270 days</description>
    <arm_group_label>Continuer at 270 Days: Edoxaban</arm_group_label>
    <arm_group_label>Discontinuer at 270 Days: Edoxaban</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin: extended treatment (e.g at least 90 days)</intervention_name>
    <description>90 days</description>
    <arm_group_label>Continuer at 90 Days: Warfarin</arm_group_label>
    <arm_group_label>Discontinuer at 90 Days: Warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin: extended treatment (e.g at least 180 days)</intervention_name>
    <description>180 days</description>
    <arm_group_label>Continuer at 180 Days: Warfarin</arm_group_label>
    <arm_group_label>Discontinuer at 180 Days: Warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin: extended treatment (e.g at least 270 days)</intervention_name>
    <description>270 days</description>
    <arm_group_label>Continuer at 270 Days: Warfarin</arm_group_label>
    <arm_group_label>Discontinuer at 270 Days: Warfarin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort derived from a commercial database, MarketScan, and Medicare Research Identifiable&#xD;
        Files using data from 2009-2015. Cohort data will be updated as new data come in through&#xD;
        2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Inpatient stay with diagnosis code of DVT/PE (see Appendix A), 1/1/2010 - 9/30/2015&#xD;
             for which the patient has at least 365 days continuous medical and pharmacy&#xD;
             eligibility prior and no other inpatient stays with DVT/PE diagnosis. Set discharge&#xD;
             date as index diagnosis date. Take only the first eligible episode for a patient, if&#xD;
             multiple.&#xD;
&#xD;
          2. Prescription fill for an anticoagulant [generic name=dabigatran (150mg), apixaban&#xD;
             (2.5mg, 5mg, 10mg), rivaroxaban (15mg, 20mg), edoxaban (30mg, 60mg), or warfarin]&#xD;
             within 30 days of and including index diagnosis date. Set earliest anticoagulant&#xD;
             prescription as index generic and date as index rx date.&#xD;
&#xD;
          3. No anticoagulant prescription fill in the 365 days prior to index diagnosis date.&#xD;
&#xD;
          4. Continuous enrollment and use of an anticoagulant for the first 90 days including and&#xD;
             following the index rx date, defined as no gaps in therapy &gt;7 days. For each patient,&#xD;
             assign a variable to indicate whether the patient filled an anticoagulant with a&#xD;
             different generic name as index during this period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any safety outcome between index diagnosis date and index rx date + 90, defined as:&#xD;
             intracranial bleed, gastrointestinal bleed, or other major bleed.&#xD;
&#xD;
          2. Any DVT/PE between index diagnosis date and index rx date + 90.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Katsiaryna Bykov, PharmD, ScD</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>dabigatran</keyword>
  <keyword>warfarin</keyword>
  <keyword>apixaban</keyword>
  <keyword>edoxaban</keyword>
  <keyword>extended treatment</keyword>
  <keyword>oral anticoagulant</keyword>
  <keyword>rivaroxaban</keyword>
  <keyword>comparative safety</keyword>
  <keyword>comparative effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
    <mesh_term>Rivaroxaban</mesh_term>
    <mesh_term>Dabigatran</mesh_term>
    <mesh_term>Apixaban</mesh_term>
    <mesh_term>Edoxaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03271450
org study id: 2017P000215
nct id: NCT03271450
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Approximately half a million Americans annually experience venous thromboembolic disease,
      including deep venous thrombosis (DVT) and pulmonary embolism (PE). Since 2010, four new oral
      anticoagulants have been approved for marketing in addition to the vitamin K antagonist
      warfarin. Very limited head-to-head data exists comparing these treatment options, leaving
      patients, clinicians, and other stakeholders with little guidance for selecting the best
      strategy that balances recurrence reduction with risk of bleeding. In the DARE Warfarin CER
      Study, the researchers compare all five currently available oral anticoagulant agents for the
      extended treatment of DVT and PE, as well as no extended treatment. This study also aims to
      evaluate whether treatment heterogeneity exists for specific populations, such as older
      patients or those with renal dysfunction. In a secondary aim, the study will also leverage a
      database of linked electronic health record-insurance claims to validate diagnosis
      definitions and account for potential residual confounding by factors unmeasured in claims
      data. As the patient population includes all Medicare novel anticoagulant users and large
      numbers of commercially insured and Medicaid patients, the results will likely be
      transportable to the majority of US patients experiencing a DVT or PE. Pursuant to the
      objectives of the Patient-Centered Outcomes Research Institute, a study advisory committee
      consisting of key stakeholders will be actively involved in the study design and
      dissemination of results.
observational model: Cohort
time perspective: Other
measure: Composite Safety Outcome: Intracranial bleed, Gastrointestinal bleed, Other Major bleed
time frame: 1-2 Years
description: Defined as a new episode of either Intracranial bleed, Gastrointestinal bleed or another Major bleed event during follow-up.
measure: Composite Effectiveness Outcome: Deep Venous Thrombosis, Pulmonary Embolism
time frame: 1-2 Years
description: Defined as a new episode of either Deep Venous Thrombosis or Pulmonary Embolism during follow-up.
measure: Death
time frame: 1-2 Years
description: Measured after index prescription date + 90 days and on date on which the event occurred and defined as hospitalization with discharge status code of: 20, 22-29, 40-42
measure: Composite safety and effectiveness outcome
time frame: 1-2 years
description: defined as earlier of safety or DVT/PE outcomes
measure: Composite safety and effectiveness outcome, including death
time frame: 1-2 years
description: Measured after index prescription date + 90 days and on date on which the event occurred and defined as hospitalization with discharge status code of: 20, 22-29, 40-42
arm group label: Continuer at 90 Days: Dabigatran
arm group label: Continuer at 180 Days: Dabigatran
arm group label: Continuer at 270 Days: Dabigatran
arm group label: Continuer at 90 Days: Apixaban
arm group label: Continuer at 180 Days: Apixaban
arm group label: Continuer at 270 Days: Apixaban
arm group label: Continuer at 90 Days: Rivaroxaban
arm group label: Continuer at 180 Days: Rivaroxaban
arm group label: Continuer at 270 Days: Rivaroxaban
arm group label: Continuer at 90 Days: Edoxaban
arm group label: Continuer at 180 Days: Edoxaban
arm group label: Continuer at 270 Days: Edoxaban
arm group label: Continuer at 90 Days: Warfarin
arm group label: Continuer at 180 Days: Warfarin
arm group label: Continuer at 270 Days: Warfarin
arm group label: Discontinuer at 90 Days: Dabigatran
arm group label: Discontinuer at 180 Days: Dabigatran
arm group label: Discontinuer at 270 Days: Dabigatran
arm group label: Discontinuer at 90 Days: Apixaban
arm group label: Discontinuer at 180 Days: Apixaban
arm group label: Discontinuer at 270 Days: Apixaban
arm group label: Discontinuer at 90 Days: Rivaroxaban
arm group label: Discontinuer at 180 Days: Rivaroxaban
arm group label: Discontinuer at 270 Days: Rivaroxaban
arm group label: Discontinuer at 90 Days: Edoxaban
arm group label: Discontinuer at 180 Days: Edoxaban
arm group label: Discontinuer at 270 Days: Edoxaban
arm group label: Discontinuer at 90 Days: Warfarin
arm group label: Discontinuer at 180 Days: Warfarin
arm group label: Discontinuer at 270 Days: Warfarin
intervention type: Drug
intervention name: Dabigatran: extended treatment (e.g at least 90 days)
description: 90 days
arm group label: Continuer at 90 Days: Dabigatran
arm group label: Discontinuer at 90 Days: Dabigatran
intervention type: Drug
intervention name: Dabigatran: extended treatment (e.g at least 180 days)
description: 180 days
arm group label: Continuer at 180 Days: Dabigatran
arm group label: Discontinuer at 180 Days: Dabigatran
intervention type: Drug
intervention name: Dabigatran: extended treatment (e.g at least 270 days)
description: 270 days
arm group label: Continuer at 270 Days: Dabigatran
arm group label: Discontinuer at 270 Days: Dabigatran
intervention type: Drug
intervention name: Apixaban: extended treatment (e.g at least 90 days)
description: 90 days
arm group label: Continuer at 90 Days: Apixaban
arm group label: Discontinuer at 90 Days: Apixaban
intervention type: Drug
intervention name: Apixaban: extended treatment (e.g at least 180 days)
description: 180 days
arm group label: Continuer at 180 Days: Apixaban
arm group label: Discontinuer at 180 Days: Apixaban
intervention type: Drug
intervention name: Apixaban: extended treatment (e.g at least 270 days)
description: 270 days
arm group label: Continuer at 270 Days: Apixaban
arm group label: Discontinuer at 270 Days: Apixaban
intervention type: Drug
intervention name: Rivaroxaban: extended treatment (e.g at least 90 days)
description: 90 days
arm group label: Continuer at 90 Days: Rivaroxaban
arm group label: Discontinuer at 90 Days: Rivaroxaban
intervention type: Drug
intervention name: Rivaroxaban: extended treatment (e.g at least 180 days)
description: 180 days
arm group label: Continuer at 180 Days: Rivaroxaban
arm group label: Discontinuer at 180 Days: Rivaroxaban
intervention type: Drug
intervention name: Rivaroxaban: extended treatment (e.g at least 270 days)
description: 270 days
arm group label: Continuer at 270 Days: Rivaroxaban
arm group label: Discontinuer at 270 Days: Rivaroxaban
intervention type: Drug
intervention name: Edoxaban: extended treatment (e.g at least 90 days)
description: 90 days
arm group label: Continuer at 90 Days: Edoxaban
arm group label: Discontinuer at 90 Days: Edoxaban
intervention type: Drug
intervention name: Edoxaban: extended treatment (e.g at least 180 days)
description: 180 days
arm group label: Continuer at 180 Days: Edoxaban
arm group label: Discontinuer at 180 Days: Edoxaban
intervention type: Drug
intervention name: Edoxaban: extended treatment (e.g at least 270 days)
description: 270 days
arm group label: Continuer at 270 Days: Edoxaban
arm group label: Discontinuer at 270 Days: Edoxaban
intervention type: Drug
intervention name: Warfarin: extended treatment (e.g at least 90 days)
description: 90 days
arm group label: Continuer at 90 Days: Warfarin
arm group label: Discontinuer at 90 Days: Warfarin
intervention type: Drug
intervention name: Warfarin: extended treatment (e.g at least 180 days)
description: 180 days
arm group label: Continuer at 180 Days: Warfarin
arm group label: Discontinuer at 180 Days: Warfarin
intervention type: Drug
intervention name: Warfarin: extended treatment (e.g at least 270 days)
description: 270 days
arm group label: Continuer at 270 Days: Warfarin
arm group label: Discontinuer at 270 Days: Warfarin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Katsiaryna Bykov, PharmD, ScD
investigator title: Instructor
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Venous Thrombosis
mesh term: Warfarin
mesh term: Rivaroxaban
mesh term: Dabigatran
mesh term: Apixaban
mesh term: Edoxaban
sharing ipd: No