Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Pragmatic randomized clinical trial
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intervention
  • Drug: Icosapent ethyl
    2 g by mouth twice daily for at least 6 months
    Other names:
    • Vascepa
No Intervention
Usual Care

Recruiting Locations

More Details

NCT ID
NCT04505098
Status
Active, not recruiting
Sponsor
Kaiser Permanente

Detailed 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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.