<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/NCT03292666</url>
  </required_header>
  <id_info>
    <org_study_id>NOACs-1510-32651</org_study_id>
    <nct_id>NCT03292666</nct_id>
  </id_info>
  <brief_title>Anticoagulation Length of ThErapy and Risk of New Adverse evenTs In Venous thromboEmbolism Study</brief_title>
  <acronym>ALTERNATIVE</acronym>
  <official_title>The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed research seeks to provide insights on the contemporary epidemiology, treatment,&#xD;
      and outcomes of VTE, including examining the uptake of new treatment strategies, the efficacy&#xD;
      and safety of different anticoagulant options, and the impact of venous thromboembolism on&#xD;
      patient-defined outcomes, such as quality-of-life, symptom burden, and treatment&#xD;
      satisfaction. This information is crucial to helping clinicians and patients choose between&#xD;
      various treatment options for venous thromboembolism in order to achieve the best possible&#xD;
      balance between the risks, benefits, and impact on health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Venous thromboembolism (VTE) is a leading cause of cardiovascular death and continues to be a&#xD;
      major public health issue in the United States. The cornerstone of current VTE treatment is&#xD;
      anticoagulation, typically given for ≥ 3 months during the acute phase of thrombosis.&#xD;
      Afterwards, extended-duration anticoagulation can be considered for selected higher-risk&#xD;
      patients. Treatment options for VTE have expanded substantially in recent years, most notably&#xD;
      through the availability of direct oral anticoagulants (DOACs). Yet there are many remaining&#xD;
      gaps in the understanding of how to manage VTE to maximize net clinical benefit.&#xD;
&#xD;
      The long-range objective of this project is to reduce the morbidity and mortality associated&#xD;
      with VTE in adults and evaluate contemporary treatment patterns and long-term outcomes after&#xD;
      VTE. This initial phase of the study will assemble an observational cohort of adults with VTE&#xD;
      diagnosed between 2010-2018. Study subjects will be identified from two integrated healthcare&#xD;
      delivery systems (Kaiser Permanente Northern California and Kaiser Permanente Southern&#xD;
      California) and followed until December, 2019. Data will be obtained from administrative and&#xD;
      electronic health records, supplemented with a cross-sectional patient survey.&#xD;
&#xD;
      The first two aims will be to compare the rates of recurrent VTE and hemorrhage between (1)&#xD;
      extended anticoagulation vs. no extended anticoagulation after VTE; and (2) DOAC vs. warfarin&#xD;
      treatment of VTE. The third specific aim is to describe patient-defined outcomes in adults&#xD;
      with VTE in the current treatment era. This will be accomplished by surveying subjects with&#xD;
      VTE to collect data on generic and disease-specific quality-of-life as well as on&#xD;
      anticoagulant treatment satisfaction. Combining clinical, outcome, and survey data with&#xD;
      administrative data will create a contemporary cohort of VTE patients that can serve as a&#xD;
      rich source of information for use in facilitating comparative effectiveness research&#xD;
      addressing optimal VTE management within real-world practice settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">June 21, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Recurrent venous thromboembolism</measure>
    <time_frame>From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019)</time_frame>
    <description>Recurrent VTE will be defined as a new VTE encounter that is occurs after the index VTE event date. The encounter must represent a new diagnosis or symptomatology that is attributable to VTE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalization for hemorrhage</measure>
    <time_frame>From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019)</time_frame>
    <description>Hospitalization for extracranial or intracranial hemorrhage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>From the index VTE date until disenrollment from the health system or the end of the planned outcome assessment (December 31, 2019)</time_frame>
    <description>All-cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>years 2018 and 2019</time_frame>
    <description>Generic health-related quality of life, measured according to the 36 item Short Form Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anticoagulant treatment satisfaction</measure>
    <time_frame>years 2018 and 2019</time_frame>
    <description>Anti-Clot Treatment Satisfaction Scale</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">39603</enrollment>
  <condition>Venous Thromboembolism</condition>
  <condition>Anticoagulants and Bleeding Disorders</condition>
  <arm_group>
    <arm_group_label>Extended anticoagulation</arm_group_label>
    <description>Patients with acute VTE treated with oral anticoagulants for &gt; 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No extended anticoagulation</arm_group_label>
    <description>Patients with acute VTE treated with oral anticoagulants for no longer than 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Anticoagulant</intervention_name>
    <description>Oral anticoagulants used to treat or prevent venous thromboembolism</description>
    <arm_group_label>Extended anticoagulation</arm_group_label>
    <other_name>warfarin, dabigatran, rivaroxaban, apixaban, edoxaban</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The source populations for the study will be adults diagnosed with acute venous&#xD;
        thromboembolism who were enrolled in Kaiser Permanente Northern California or Kaiser&#xD;
        Permanente Southern California, two large, integrated healthcare delivery systems in&#xD;
        California.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (age ≥ 18 years) enrolled in Kaiser Permanente Northern California or Kaiser&#xD;
             Permanente Southern California&#xD;
&#xD;
          -  Index VTE event, defined as an incident clinical encounter (inpatient, emergency&#xD;
             department, or outpatient) with a primary or secondary diagnosis of VTE during the&#xD;
             time period January 1, 2010 to December 31, 2018&#xD;
&#xD;
          -  Anticoagulant prescription (oral or parenteral) filled after index VTE&#xD;
             discharge/encounter date&#xD;
&#xD;
          -  Continuous outpatient anticoagulant therapy for ≥ 3 months from fill date of&#xD;
             prescription&#xD;
&#xD;
          -  Continuous pharmacy benefits and health plan membership for at least 12 months before&#xD;
             the index VTE event date&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Incomplete information on age and sex&#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>Margaret C. Fang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Northern California</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Southern California</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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>Anticoagulants</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/NCT03292666
org study id: NOACs-1510-32651
nct id: NCT03292666
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The proposed research seeks to provide insights on the contemporary epidemiology, treatment,
      and outcomes of VTE, including examining the uptake of new treatment strategies, the efficacy
      and safety of different anticoagulant options, and the impact of venous thromboembolism on
      patient-defined outcomes, such as quality-of-life, symptom burden, and treatment
      satisfaction. This information is crucial to helping clinicians and patients choose between
      various treatment options for venous thromboembolism in order to achieve the best possible
      balance between the risks, benefits, and impact on health.
Venous thromboembolism (VTE) is a leading cause of cardiovascular death and continues to be a
      major public health issue in the United States. The cornerstone of current VTE treatment is
      anticoagulation, typically given for ≥ 3 months during the acute phase of thrombosis.
      Afterwards, extended-duration anticoagulation can be considered for selected higher-risk
      patients. Treatment options for VTE have expanded substantially in recent years, most notably
      through the availability of direct oral anticoagulants (DOACs). Yet there are many remaining
      gaps in the understanding of how to manage VTE to maximize net clinical benefit.

      The long-range objective of this project is to reduce the morbidity and mortality associated
      with VTE in adults and evaluate contemporary treatment patterns and long-term outcomes after
      VTE. This initial phase of the study will assemble an observational cohort of adults with VTE
      diagnosed between 2010-2018. Study subjects will be identified from two integrated healthcare
      delivery systems (Kaiser Permanente Northern California and Kaiser Permanente Southern
      California) and followed until December, 2019. Data will be obtained from administrative and
      electronic health records, supplemented with a cross-sectional patient survey.

      The first two aims will be to compare the rates of recurrent VTE and hemorrhage between (1)
      extended anticoagulation vs. no extended anticoagulation after VTE; and (2) DOAC vs. warfarin
      treatment of VTE. The third specific aim is to describe patient-defined outcomes in adults
      with VTE in the current treatment era. This will be accomplished by surveying subjects with
      VTE to collect data on generic and disease-specific quality-of-life as well as on
      anticoagulant treatment satisfaction. Combining clinical, outcome, and survey data with
      administrative data will create a contemporary cohort of VTE patients that can serve as a
      rich source of information for use in facilitating comparative effectiveness research
      addressing optimal VTE management within real-world practice settings.
observational model: Cohort
time perspective: Retrospective
measure: Recurrent venous thromboembolism
time frame: From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019)
description: Recurrent VTE will be defined as a new VTE encounter that is occurs after the index VTE event date. The encounter must represent a new diagnosis or symptomatology that is attributable to VTE.
measure: Hospitalization for hemorrhage
time frame: From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019)
description: Hospitalization for extracranial or intracranial hemorrhage
measure: Death
time frame: From the index VTE date until disenrollment from the health system or the end of the planned outcome assessment (December 31, 2019)
description: All-cause death
measure: Health-related quality of life
time frame: years 2018 and 2019
description: Generic health-related quality of life, measured according to the 36 item Short Form Survey
measure: Anticoagulant treatment satisfaction
time frame: years 2018 and 2019
description: Anti-Clot Treatment Satisfaction Scale
arm group label: Extended anticoagulation
description: Patients with acute VTE treated with oral anticoagulants for > 3 months
arm group label: No extended anticoagulation
description: Patients with acute VTE treated with oral anticoagulants for no longer than 3 months
intervention type: Drug
intervention name: Oral Anticoagulant
description: Oral anticoagulants used to treat or prevent venous thromboembolism
arm group label: Extended anticoagulation
other name: warfarin, dabigatran, rivaroxaban, apixaban, edoxaban
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margaret C. Fang, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Warfarin
mesh term: Rivaroxaban
mesh term: Dabigatran
mesh term: Apixaban
mesh term: Anticoagulants
mesh term: Edoxaban
sharing ipd: No