A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

NCT ID: NCT04505098

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 39600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2022-12-15

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).

Conditions

Covid19; Atherosclerosis; Cardiovascular Diseases; Upper Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Group Type: ACTIVE_COMPARATOR

Icosapent ethyl

Intervention Type: DRUG

2 g by mouth twice daily for at least 6 months

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Icosapent ethyl

2 g by mouth twice daily for at least 6 months

Intervention Type: DRUG

Other Intervention Names

Vascepa

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amarin Corporation

UNKNOWN

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Research

Oakland, California, United States

Countries

United States

Other Identifiers

1597940

Identifier Type: -

Identifier Source: org_study_id