Atherosclerosis, Cardiovascular Diseases, Covid19, Upper Respiratory Tract Infections
Conditions
Brief 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).
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).
Interventions
DRUGIcosapent ethyl
2 g by mouth twice daily for at least 6 months
Sponsors
Amarin Corporation
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pragmatic randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of confirmed viral URIs | 0-12 months | Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with moderate or severe confirmed viral URIs | 0-12 months | Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation \<94% on room air and/or requiring any form of supplemental oxygen. |
| Worst clinical status due to a confirmed viral URI | 0-12 months | At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who are hospitalized for heart failure | 0-12 months | — |
| Percentage of participants who die due to any cause | 0-12 months | — |
| Percentage of participants who have an emergency department visit for any reason | 0-12 months | — |
| Percentage of participants who are hospitalized for any reason | 0-12 months | — |
| Percentage of participants experiencing a major adverse cardiovascular event | 0-12 months | Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke |
| Percentage of participants experiencing an expanded major adverse cardiovascular event | 0-12 months | Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft) |
Countries
United States
Outcome results
None listed