A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerosis
- Cardiovascular Diseases
- COVID-19
- Upper Respiratory Tract Infections
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Pragmatic randomized clinical trialMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
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 ...
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).
Tracking Information
- NCT #
- NCT04505098
- Collaborators
- Amarin Corporation
- Investigators
- Principal Investigator: Andrew Ambrosy, M.D. Kaiser Permanente Principal Investigator: Alan S Go, M.D. Kaiser Permanente
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