<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/NCT04505098</url>
  </required_header>
  <id_info>
    <org_study_id>1597940</org_study_id>
    <nct_id>NCT04505098</nct_id>
  </id_info>
  <brief_title>A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults</brief_title>
  <acronym>MITIGATE</acronym>
  <official_title>A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amarin Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>Yes</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>
      MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial.&#xD;
      The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of&#xD;
      pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard&#xD;
      of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory&#xD;
      infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory&#xD;
      pathogens) morbidity and mortality in a high-risk cohort of adults with established&#xD;
      atherosclerotic cardiovascular disease (ASCVD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For the MITIGATE study, eligible members receiving care within Kaiser Permanente Northern&#xD;
      California (KPNC) will be identified and screened electronically in a 1:10 intervention to&#xD;
      control allocation (i.e., IPE vs. usual care) stratified by age and pre-existing respiratory&#xD;
      status. Patients randomly assigned and enrolled into the intervention arm will be asked to&#xD;
      take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion.&#xD;
      Patients assigned to the control arm (i.e., usual care) will be passively followed only&#xD;
      electronically via the electronic health record (EHR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was suspended by the IRB of record and subsequently terminated&#xD;
  </why_stopped>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">December 15, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pragmatic randomized clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of confirmed viral URIs</measure>
    <time_frame>0-12 months</time_frame>
    <description>Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with moderate or severe confirmed viral URIs</measure>
    <time_frame>0-12 months</time_frame>
    <description>Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation &lt;94% on room air and/or requiring any form of supplemental oxygen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst clinical status due to a confirmed viral URI</measure>
    <time_frame>0-12 months</time_frame>
    <description>At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of participants who die due to any cause</measure>
    <time_frame>0-12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants experiencing a major adverse cardiovascular event</measure>
    <time_frame>0-12 months</time_frame>
    <description>Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants experiencing an expanded major adverse cardiovascular event</measure>
    <time_frame>0-12 months</time_frame>
    <description>Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants who are hospitalized for heart failure</measure>
    <time_frame>0-12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants who are hospitalized for any reason</measure>
    <time_frame>0-12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants who have an emergency department visit for any reason</measure>
    <time_frame>0-12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39600</enrollment>
  <condition>Covid19</condition>
  <condition>Atherosclerosis</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Upper Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icosapent ethyl</intervention_name>
    <description>2 g by mouth twice daily for at least 6 months</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Vascepa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide informed consent (for the intervention arm only)&#xD;
&#xD;
          -  No prior history of confirmed COVID-19 (i.e., based on a positive FDA-approved assay&#xD;
             for SARS-CoV-2 and no documented FDA-approved serological test results for antibodies&#xD;
             to SARS-CoV-2 found in health system databases)&#xD;
&#xD;
          -  Established ASCVD (i.e., defined as prior myocardial infarction, percutaneous coronary&#xD;
             intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral&#xD;
             artery disease)&#xD;
&#xD;
          -  At least 12 months of continuous health plan membership and prescription drug benefit&#xD;
             prior to enrollment&#xD;
&#xD;
          -  A registered e-mail address with the health care delivery system in order to&#xD;
             facilitate obtaining electronic consent for study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of IPE on or within 12 months before the day of enrollment&#xD;
&#xD;
          -  Known hypersensitivity to IPE, fish, and/or shellfish&#xD;
&#xD;
          -  Documented use of any omega-3 fatty acid medications or dietary supplements containing&#xD;
             omega-3 fatty acids in the EHR&#xD;
&#xD;
          -  Women who are pregnant or planning to become pregnant&#xD;
&#xD;
          -  Hospitalization for myocardial infarction and/or elective percutaneous coronary&#xD;
             intervention within the past 1 month&#xD;
&#xD;
          -  Currently receiving triple anti-thrombotic therapy&#xD;
&#xD;
          -  Stage D heart failure&#xD;
&#xD;
          -  Severe liver disease&#xD;
&#xD;
          -  End-stage renal disease requiring chronic dialysis or estimated glomerular filtration&#xD;
             rate &lt;15 mL/min/1.73 m2&#xD;
&#xD;
          -  Metastatic cancer and/or receiving active systemic chemotherapy&#xD;
&#xD;
          -  Institutionalized and/or receiving palliative care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Research</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</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>Respiratory Tract Infections</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eicosapentaenoic acid ethyl ester</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/NCT04505098
org study id: 1597940
nct id: NCT04505098
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial.
      The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of
      pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard
      of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory
      infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory
      pathogens) morbidity and mortality in a high-risk cohort of adults with established
      atherosclerotic cardiovascular disease (ASCVD).
For the MITIGATE study, eligible members receiving care within Kaiser Permanente Northern
      California (KPNC) will be identified and screened electronically in a 1:10 intervention to
      control allocation (i.e., IPE vs. usual care) stratified by age and pre-existing respiratory
      status. Patients randomly assigned and enrolled into the intervention arm will be asked to
      take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion.
      Patients assigned to the control arm (i.e., usual care) will be passively followed only
      electronically via the electronic health record (EHR).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pragmatic randomized clinical trial
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Rate of confirmed viral URIs
time frame: 0-12 months
description: Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities)
measure: Percentage of patients with moderate or severe confirmed viral URIs
time frame: 0-12 months
description: Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation <94% on room air and/or requiring any form of supplemental oxygen.
measure: Worst clinical status due to a confirmed viral URI
time frame: 0-12 months
description: At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters)
measure: Percentage of participants who die due to any cause
time frame: 0-12 months
measure: Percentage of participants experiencing a major adverse cardiovascular event
time frame: 0-12 months
description: Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke
measure: Percentage of participants experiencing an expanded major adverse cardiovascular event
time frame: 0-12 months
description: Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)
measure: Percentage of participants who are hospitalized for heart failure
time frame: 0-12 months
measure: Percentage of participants who are hospitalized for any reason
time frame: 0-12 months
measure: Percentage of participants who have an emergency department visit for any reason
time frame: 0-12 months
arm group label: Intervention
arm group type: Active Comparator
arm group label: Usual Care
arm group type: No Intervention
intervention type: Drug
intervention name: Icosapent ethyl
description: 2 g by mouth twice daily for at least 6 months
arm group label: Intervention
other name: Vascepa
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
mesh term: Eicosapentaenoic acid ethyl ester
sharing ipd: No