Status:
TERMINATED
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Amarin Corporation
Conditions:
Covid19
Atherosclerosis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 wit...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
39600 Patients enrolled
Trial Details
Trial ID
NCT04505098
Start Date
August 7 2020
End Date
December 15 2022
Last Update
July 18 2023
Active Locations (1)
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1
Division of Research
Oakland, California, United States, 94612