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

1597940

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).

2020-08-07

2022-12-15

2022-12-15

Terminated

Early phase I

39600

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

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2023-07-18