A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (NCT04505098) | Clinical Trial Compass
TerminatedPhase 4
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Stopped: The study was suspended by the IRB of record and subsequently terminated
United States39,600 participantsStarted 2020-08-07
Plain-language 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).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 receiv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.