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A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults in the Era of Coronavirus Disease 2019
Overall Recruitment Status: Enrollment not started
Official Title
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults in the Era of Coronavirus Disease 2019
Region Sponsors
California - Northern
Amarin Corporation
Kaiser Permanente
Acronym KP IRB No.
MITIGATE 1597940
Study Type Phase
Clinical Trial Phase IV
Study Population Description
Adults with established atherosclerotic cardiovascular disease (ASCVD).
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) compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (for example, COVID-19, influenza, or other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD)
Detailed Description
Eligible members receiving care within Kaiser Permanente Northern California (KPNC) will be identified from electronic health records and randomized to be offered IPE vs. continuing 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).
Gender Age Limit
Male & Female 50 years & older
Inclusion Criteria
  • No prior history of confirmed coronavirus disease 2019 (COVID-19) based on a positive FDA-approved assay for SARS-CoV-2 or no documented FDA-approved serological test results for antibodies to SARS-CoV-2 found in health system databases
  • Documented 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

Keywords and/or Specific Medical Conditions
  • Arterial Occlusive Diseases
  • Infectious Diseases
  • Arteriosclerosis
  • Platelet Aggregation Inhibitors
  • Atherosclerosis
  • Respiratory Tract Diseases
  • Cardiology
  • Respiratory Tract Infections
  • Cardiovascular Diseases
  • Vascular Diseases
  • Eicosapentaenoic acid ethyl ester
  • Cardiology
  • Infection
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
Clinical Area
  • Cardiology
  • Infectious Diseases

Principal Investigator:
Andrew P Ambrosy, MD
Contact Information:
- Alan S Go, MD
-Regional Locations-DOR
- Thida C Tan, MPH
-Regional Locations-DOR

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