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).
Drug: Icosapent ethyl
2 g by mouth twice daily for at least 6 months
Other Name: Vascepa
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
Kaiser Permanente Northern California
Oakland, California, United States