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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 is a Phase 4 study that was terminated before completion, run by Kaiser Permanente. The registered enrollment target is 39,600 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04505098
The ClinicalTrials.gov registry entry for NCT04505098 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 39,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Icosapent ethyl is the first listed.
NCT04505098 reports 0 study locations.
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.
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