<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/NCT02248610</url>
  </required_header>
  <id_info>
    <org_study_id>FIRST registry</org_study_id>
    <nct_id>NCT02248610</nct_id>
  </id_info>
  <brief_title>Follow-up in Rivaroxaban Patients in Setting of Thromboembolism</brief_title>
  <acronym>FIRST</acronym>
  <official_title>Follow-up in Rivaroxaban Patients in Setting of Thromboembolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College Hospital NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators&#xD;
      will collect real world data on their short and long term outcomes. The investigators&#xD;
      hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will&#xD;
      be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2.&#xD;
      there will be less bleeding than when patients are on conventional anticoagulants; 3. there&#xD;
      will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary&#xD;
      hypertension and post-thrombotic limb syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      United Kingdom-only prospective, non-interventional, investigator-led, multi-centre, single&#xD;
      cohort, registry. The observation period for each patient covers the treatment period with&#xD;
      rivaroxaban and follow up until study end. For each patient, the treating health care&#xD;
      professional records patient demographics, medical history, signs and symptoms, diagnosis,&#xD;
      treatment and safety parameters at an initial visit and subsequent follow-up visit(s). Data&#xD;
      monitoring will be undertaken by the Sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</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>5 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of long term complications</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
    <description>Incidence of long term complications as composite primary end point of VTE recurrence, PTS and CTEPH in patients treated with rivaroxaban without bridging heparin therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of major post-thrombotic complications</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
    <description>Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent bleeding rates</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
    <description>Long-term treatment-emergent bleeding rates (up to 5 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment adherence</measure>
    <time_frame>Full duration of anticoagulation treatment (average of 6 months)</time_frame>
    <description>Adherence will be measured by patient interviews with a validated questionnaire conducted during follow-up visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>Full duration of anticoagulation treatment (average of 6 months)</time_frame>
    <description>Regular quality of life assessment in patients diagnosed with VTE, three questionnaires to be completed at time of index event, then at second and then final clinic visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilisation</measure>
    <time_frame>Full duration of anticoagulation treatment (average of 6 months)</time_frame>
    <description>Healthcare resource utilisation in patients treated with long-term (&gt;12 months) anticoagulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of other thromboembolic events</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
    <description>Long-term incidence rates of other thromboembolic events (e.g. myocardial infarction and ischaemic stroke).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory root-cause analysis of major bleeding and recurrent VTE events</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Analysis of the outpatient treatment of PE</measure>
    <time_frame>Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits)</time_frame>
    <description>To assess outcomes with specific reference to the patient journey (outpatient, inpatient and primary care), with particular focus on outpatient treatment of PE.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup analysis of patients with evidence of long-term VTE-related morbidity</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
    <description>To identify subgroups at higher risk of adverse events (AE) and/or long-term VTE-related morbidity (PTS and CTEPH).</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of rivaroxaban in under-studied groups</measure>
    <time_frame>5 years from diagnosis of index event (DVT or PE), annual follow-up</time_frame>
    <description>To evaluate risks of rivaroxaban in patient populations for which safety information is limited or missing (eg pregnancy, breastfeeding, patients with significant organ impairment, extremes of age).</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1343</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>All participants will be treated with rivaroxaban.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional study</intervention_name>
    <arm_group_label>Rivaroxaban</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have&#xD;
        not recieved bridging anticoagulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or&#xD;
             PE and treated according to routine clinical practice with Rivaroxaban&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom follow-up is unlikely or impossible&#xD;
&#xD;
          -  Patients unable to give consent&#xD;
&#xD;
          -  Patients who receive heparin therapy for more than 48 hours&#xD;
&#xD;
          -  Patients who receive more than one dose of warfarin&#xD;
&#xD;
          -  Patients with an indication for anticoagulation other than DVT and/or PE&#xD;
&#xD;
          -  All contraindications listed in the local product information (SmPC) will form part of&#xD;
             the exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roopen Arya, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College Hospital NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Basingstoke Hospital</name>
      <address>
        <city>Basingstoke</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salisbury Hospital</name>
      <address>
        <city>Salisbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary embolism</keyword>
  <keyword>PE</keyword>
  <keyword>Deep vein thrombosis</keyword>
  <keyword>DVT</keyword>
  <keyword>Rivaroxaban</keyword>
  <keyword>Venous thromboembolism</keyword>
  <keyword>Chronic thromboembolic pulmonary hypertension</keyword>
  <keyword>Post thrombotic limb syndrome</keyword>
  <keyword>Root cause analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</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/NCT02248610
org study id: FIRST registry
nct id: NCT02248610
lead sponsor: 
collaborator: 
has dmc: Yes
In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators
      will collect real world data on their short and long term outcomes. The investigators
      hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will
      be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2.
      there will be less bleeding than when patients are on conventional anticoagulants; 3. there
      will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary
      hypertension and post-thrombotic limb syndrome.
United Kingdom-only prospective, non-interventional, investigator-led, multi-centre, single
      cohort, registry. The observation period for each patient covers the treatment period with
      rivaroxaban and follow up until study end. For each patient, the treating health care
      professional records patient demographics, medical history, signs and symptoms, diagnosis,
      treatment and safety parameters at an initial visit and subsequent follow-up visit(s). Data
      monitoring will be undertaken by the Sponsor.
observational model: Cohort
time perspective: Prospective
measure: Incidence of long term complications
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
description: Incidence of long term complications as composite primary end point of VTE recurrence, PTS and CTEPH in patients treated with rivaroxaban without bridging heparin therapy
measure: Incidence of major post-thrombotic complications
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
description: Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH)
measure: Incidence of treatment-emergent bleeding rates
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
description: Long-term treatment-emergent bleeding rates (up to 5 years).
measure: All-cause mortality
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: Treatment adherence
time frame: Full duration of anticoagulation treatment (average of 6 months)
description: Adherence will be measured by patient interviews with a validated questionnaire conducted during follow-up visits.
measure: Quality of life assessment
time frame: Full duration of anticoagulation treatment (average of 6 months)
description: Regular quality of life assessment in patients diagnosed with VTE, three questionnaires to be completed at time of index event, then at second and then final clinic visits.
measure: Healthcare resource utilisation
time frame: Full duration of anticoagulation treatment (average of 6 months)
description: Healthcare resource utilisation in patients treated with long-term (>12 months) anticoagulation
measure: Incidence of other thromboembolic events
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
description: Long-term incidence rates of other thromboembolic events (e.g. myocardial infarction and ischaemic stroke).
measure: Exploratory root-cause analysis of major bleeding and recurrent VTE events
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: Analysis of the outpatient treatment of PE
time frame: Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits)
description: To assess outcomes with specific reference to the patient journey (outpatient, inpatient and primary care), with particular focus on outpatient treatment of PE.
measure: Subgroup analysis of patients with evidence of long-term VTE-related morbidity
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
description: To identify subgroups at higher risk of adverse events (AE) and/or long-term VTE-related morbidity (PTS and CTEPH).
measure: Evaluation of rivaroxaban in under-studied groups
time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
description: To evaluate risks of rivaroxaban in patient populations for which safety information is limited or missing (eg pregnancy, breastfeeding, patients with significant organ impairment, extremes of age).
arm group label: Rivaroxaban
description: All participants will be treated with rivaroxaban.
intervention type: Other
intervention name: Non-interventional study
arm group label: Rivaroxaban
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Roopen Arya, MBChB, PhD
role: Principal Investigator
affiliation: King's College Hospital NHS Trust
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism