A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 39,600
- 试验地点
- 1
- 主要终点
- Rate of confirmed viral URIs
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent (for the intervention arm only)
- •No prior history of confirmed COVID-19 (i.e., based on a positive FDA-approved assay for SARS-CoV-2 and no documented FDA-approved serological test results for antibodies to SARS-CoV-2 found in health system databases)
- •Established ASCVD (i.e., defined as prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral artery disease)
- •At least 12 months of continuous health plan membership and prescription drug benefit prior to enrollment
- •A registered e-mail address with the health care delivery system in order to facilitate obtaining electronic consent for study participation
排除标准
- •Receipt of IPE on or within 12 months before the day of enrollment
- •Known hypersensitivity to IPE, fish, and/or shellfish
- •Documented use of any omega-3 fatty acid medications or dietary supplements containing omega-3 fatty acids in the EHR
- •Women who are pregnant or planning to become pregnant
- •Hospitalization for myocardial infarction and/or elective percutaneous coronary intervention within the past 1 month
- •Currently receiving triple anti-thrombotic therapy
- •Stage D heart failure
- •Severe liver disease
- •End-stage renal disease requiring chronic dialysis or estimated glomerular filtration rate <15 mL/min/1.73 m2
- •Metastatic cancer and/or receiving active systemic chemotherapy
- •Institutionalized and/or receiving palliative care
研究组 & 干预措施
Intervention
干预措施: Icosapent ethyl (Drug)
结局指标
主要结局
Rate of confirmed viral URIs
时间窗: 0-12 months
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)
次要结局
- Worst clinical status due to a confirmed viral URI(0-12 months)
- Percentage of patients with moderate or severe confirmed viral URIs(0-12 months)