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

NCT04505098 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 39600

Last updated 2023-07-18

No results posted yet for this study

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

Interventions

DRUG

Icosapent ethyl

2 g by mouth twice daily for at least 6 months

Sponsors & Collaborators

  • Amarin Corporation

    collaborator UNKNOWN

  • Kaiser Permanente

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2022-12-15
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505098 on ClinicalTrials.gov