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

NCT04505098 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 1597940
• Study Type: interventional
• Target: 39,600
• Locations: 1 country
• Sites: 1

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).

Conditions

Covid19; Atherosclerosis; Cardiovascular Diseases; Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Rate of confirmed viral URIs

  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)

  0-12 months

Secondary Outcomes (2)

• Percentage of patients with moderate or severe confirmed viral URIs

  0-12 months

• Worst clinical status due to a confirmed viral URI

  0-12 months

Other Outcomes (6)

• Percentage of participants who die due to any cause

  0-12 months

• Percentage of participants experiencing a major adverse cardiovascular event

  0-12 months

• Percentage of participants experiencing an expanded major adverse cardiovascular event

  0-12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Drug: Icosapent ethyl

Usual Care

NO INTERVENTION

Interventions

Icosapent ethyl DRUG

2 g by mouth twice daily for at least 6 months

Also known as: Vascepa

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Amarin Corporation: collaborator

Study Sites (1)

Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

COVID-19; Atherosclerosis; Cardiovascular Diseases; Respiratory Tract Infections

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized clinical trial

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: August 7, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)