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

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: Amarin Corporation
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

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