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

Kaiser Permanente

Status and phase

Terminated

Phase 4

Conditions

Covid19

Upper Respiratory Tract Infections

Cardiovascular Diseases

Atherosclerosis

Treatments

Drug: Icosapent ethyl

Study type

Interventional

Funder types

Other

Identifiers

NCT04505098

1597940

Details and patient eligibility

About

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).

Full description

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).

Enrollment

39,600 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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