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NCT04505098 · ClinicalTrials.gov registry record · Phase 4
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
A Phase 4 study, sponsored by Kaiser Permanente.
- Terminated
- Registry status
- Phase 4
- Development phase
- 39,600
- Enrollment target
NCT04505098: Clinical Trial Phase 4 study, sponsored by Kaiser Permanente.
NCT04505098 is a Phase 4 study that was terminated before completion, run by Kaiser Permanente. The registered enrollment target is 39,600 participants, above the 514-participant average among 9,235 other Phase 4 trials with a reported enrollment target (7604% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505098, a Phase 4 study, was terminated before completion, sponsored by Kaiser Permanente.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 39,600 participants
- Enrollment target
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).
Primary Outcome
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)
Interventions
- DRUG Icosapent ethyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39,600 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 4 |
Why NCT04505098 stopped before completion
NCT04505098 is an interventional study that assigns participants to a tested intervention. Its 39,600 participants enrollment target places it among the larger protocols in the corpus, above the 514-participant average among 9,235 other Phase 4 trials with a reported enrollment target (7604% higher).
The record links to 0 conditions, and to 1 intervention - of which Icosapent ethyl is the first listed.
NCT04505098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04505098 about?
NCT04505098 is a clinical study titled "A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults". 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 r...
What is the current status of trial NCT04505098?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 39,600 participants. The study started on 2020-08-07. Estimated completion is 2022-12-15.
What interventions are being tested in trial NCT04505098?
The interventions under investigation include: Icosapent ethyl (DRUG).
Who is sponsoring clinical trial NCT04505098?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04505098's enrollment target sits among peer trials
39,600 4th of 2000 higher than 1,997 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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