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

Stopped early · Phase 4

Conditions studied: Covid19, Atherosclerosis, Cardiovascular Diseases, Upper Respiratory Tract Infections

In brief

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).

Key facts

Study ID

NCT04505098

Run by

Kaiser Permanente

People needed

39600

Starts

2020-08-07

Expected to finish

2022-12-15

Last updated by the study team

2023-07-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Division of Research — Oakland, California, United States

Full record on ClinicalTrials.gov

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