Trials / Terminated
TerminatedNCT04505098
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 39,600 (actual)
- Sponsor
- Kaiser Permanente · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
For the MITIGATE study, eligible members receiving care within Kaiser Permanente Northern California (KPNC) will be identified and screened electronically in a 1:10 intervention to control allocation (i.e., IPE vs. usual care) stratified by age and pre-existing respiratory status. Patients randomly assigned and enrolled into the intervention arm will be asked to take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion. Patients assigned to the control arm (i.e., usual care) will be passively followed only electronically via the electronic health record (EHR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Icosapent ethyl | 2 g by mouth twice daily for at least 6 months |
Timeline
- Start date
- 2020-08-07
- Primary completion
- 2022-12-15
- Completion
- 2022-12-15
- First posted
- 2020-08-10
- Last updated
- 2023-07-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04505098. Inclusion in this directory is not an endorsement.