Abstract
Objective: The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD).
Background: IPE is a highly purified and stable omega-3 fatty acid prescription medication that is approved for cardiovascular risk reduction in high-risk adults on statin therapy with elevated triglycerides. Preclinical data and clinical observations suggest that IPE may have pleiotropic effects including antiviral and anti-inflammatory properties that may prevent or reduce the downstream sequelae and cardiopulmonary consequences of viral URIs.
Methods: MITIGATE is a virtual, electronic health record-based, open-label, randomized, pragmatic clinical trial enrolling ∼16,500 participants within Kaiser Permanente Northern California – a fully integrated and learning health care delivery system with 21 hospitals and >255 ambulatory clinics serving ∼4.5 million members. Adults ≥50 years with established ASCVD and no prior history of coronavirus disease 2019 (COVID-19) will be prospectively identified and pre-randomized in a 1:10 allocation ratio (∼ 1,500 IPE: ∼15,000 usual care) stratified by age and previous respiratory health status to the intervention (IPE 2 grams by mouth twice daily with meals) vs the control group (usual care) for a minimum follow-up duration of 6 months. The co-primary endpoints are moderate-to-severe laboratory-confirmed viral URI and worst clinical status due to a viral URI at any point in time.
Conclusion: The MITIGATE study will inform clinical practice by providing evidence on the real-world clinical effectiveness of pretreatment with IPE to prevent and/or reduce the sequelae of laboratory-confirmed viral URIs in a high-risk cohort of patients with established ASCVD.
Keywords: Atherosclerotic cardiovascular disease; coronavirus disease 2019; icosapent ethyl; seasonal flu; triglycerides; viral upper respiratory infection.
【저자키워드】 Coronavirus disease 2019, Atherosclerotic cardiovascular disease, icosapent ethyl, seasonal flu, triglycerides, viral upper respiratory infection., 【초록키워드】 COVID-19, coronavirus disease, Coronavirus disease 2019, clinical trial, therapy, Health care, Open-label, Antiviral, omega-3, hospital, Cardiopulmonary, cardiovascular disease, Intervention, clinics, clinical status, Randomized, respiratory infection, Health, cardiovascular risk, statin, clinical effectiveness, age, Health status, morbidity and mortality, Follow-up, Care, Fatty acid, Clinical practice, clinical observations, Evidence, Pleiotropic effects, icosapent ethyl, seasonal flu, triglycerides, Pragmatic, by mouth, omega-3 fatty acid, control group, atherosclerotic, usual care, upper respiratory infection, participant, mouth, laboratory-confirmed, downstream, prescription medication, preclinical data, mitigate, Prevent, consequence, co-primary endpoints, Icosapent, evaluate, approved, elevated, reduce, reduction in, purified, stratified, anti-inflammatory property, clinical observation, co-primary endpoint, cohort of patient, fatty, pleiotropic effect, Preclinical, 【제목키워드】 randomized trial, cardiovascular risk, icosapent ethyl, Pragmatic, rationale,