MITIGATE: A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention
|
Drug: Icosapent ethyl
2 g by mouth twice daily for at least 6 months
Other Names:
|
| No Intervention: Usual Care
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- Percentage of participants who die due to any cause [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)
- Percentage of participants who are hospitalized for heart failure [0-12 months]
- Percentage of participants who are hospitalized for any reason [0-12 months]
- Percentage of participants who have an emergency department visit for any reason [0-12 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Northern California | Oakland | California | United States | 94612 |
Sponsors and Collaborators
- Kaiser Permanente
- Amarin Corporation
Investigators
- Principal Investigator: Andrew Ambrosy, M.D., Kaiser Permanente
- Principal Investigator: Alan S Go, M.D., Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1597940