drugset / Trial / NCT04505098

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

NCT04505098

Phase 4 Terminated 39600 enrolled Kaiser Permanente Amarin Corporation · collab
RandomizedParallel-groupSingle-blindPrevention

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).

Timeline

Start
2020-08-07
Primary completion
2022-12-15
Completion
2022-12-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator icosapent ethyl Small molecule 2 g Oral