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A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04505098
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : September 8, 2021
Amarin Corporation
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Covid19 Atherosclerosis Cardiovascular Diseases Upper Respiratory Tract Infections Drug: Icosapent ethyl Phase 4

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intervention Drug: Icosapent ethyl
2 g by mouth twice daily for at least 6 months
Other Name: Vascepa

No Intervention: Usual Care

Primary Outcome Measures :
  1. Percentage of patients with moderate or severe confirmed viral URIs [ Time Frame: 0-12 months ]
    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.

  2. Worst clinical status due to a confirmed viral URI [ Time Frame: 0-12 months ]
    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)

Other Outcome Measures:
  1. Percentage of participants who die due to any cause [ Time Frame: 0-12 months ]
  2. Percentage of participants experiencing a major adverse cardiovascular event [ Time Frame: 0-12 months ]
    Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke

  3. Percentage of participants experiencing an expanded major adverse cardiovascular event [ Time Frame: 0-12 months ]
    Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)

  4. Percentage of participants who are hospitalized for heart failure [ Time Frame: 0-12 months ]
  5. Percentage of participants who are hospitalized for any reason [ Time Frame: 0-12 months ]
  6. Percentage of participants who have an emergency department visit for any reason [ Time Frame: 0-12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able to provide informed consent (for the intervention arm only)
  • No prior history of confirmed COVID-19 (i.e., based on a positive FDA-approved assay for SARS-CoV-2 and no documented FDA-approved serological test results for antibodies to SARS-CoV-2 found in health system databases)
  • Established ASCVD (i.e., defined as prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral artery disease)
  • At least 12 months of continuous health plan membership and prescription drug benefit prior to enrollment
  • A registered e-mail address with the health care delivery system in order to facilitate obtaining electronic consent for study participation

Exclusion Criteria:

  • Receipt of IPE on or within 12 months before the day of enrollment
  • Known hypersensitivity to IPE, fish, and/or shellfish
  • Documented use of any omega-3 fatty acid medications or dietary supplements containing omega-3 fatty acids in the EHR
  • Women who are pregnant or planning to become pregnant
  • Hospitalization for myocardial infarction and/or elective percutaneous coronary intervention within the past 1 month
  • Currently receiving triple anti-thrombotic therapy
  • Stage D heart failure
  • Severe liver disease
  • End-stage renal disease requiring chronic dialysis or estimated glomerular filtration rate <15 mL/min/1.73 m2
  • Metastatic cancer and/or receiving active systemic chemotherapy
  • Institutionalized and/or receiving palliative care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04505098

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Contact: Alan S Go, M.D. 510-891-3422
Contact: Andrew P Ambrosy, M.D.

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United States, California
Kaiser Permanente Northern California Recruiting
Oakland, California, United States, 94612
Contact: Alan Go, MD         
Sponsors and Collaborators
Kaiser Permanente
Amarin Corporation
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Principal Investigator: Andrew Ambrosy, M.D. Kaiser Permanente
Principal Investigator: Alan S Go, M.D. Kaiser Permanente
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Responsible Party: Kaiser Permanente Identifier: NCT04505098    
Other Study ID Numbers: 1597940
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Cardiovascular Diseases
Respiratory Tract Diseases
Arterial Occlusive Diseases
Vascular Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Lipid Regulating Agents