A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
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
- Covid19
- Atherosclerosis
- Cardiovascular Diseases
- Upper Respiratory Tract Infections
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
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Intervention |
|
|
No Intervention Usual Care |
|
Recruiting Locations
More Details
- NCT ID
- NCT04505098
- Status
- Terminated
- 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).