Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA; Division of Research, Kaiser Permanente Northern California, Oakland, CA.
Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA.
Am Heart J. 2021 May;235:54-64. doi: 10.1016/j.ahj.2021.01.018. Epub 2021 Jan 28.
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).
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.
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.
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.
MITIGATE 研究旨在评估与常规治疗相比，在已确诊动脉粥样硬化性心血管疾病（ASCVD）的成人中，在实验室确诊的病毒上呼吸道感染（URI）相关发病率和死亡率方面，在用他汀类药物治疗且甘油三酯升高的高危成人中，预先使用依泽替米贝（IPE）的真实世界临床疗效。
IPE 是一种高度纯化和稳定的ω-3 脂肪酸处方药，批准用于降低高危他汀类药物治疗且甘油三酯升高的成人的心血管风险。临床前数据和临床观察表明，IPE 可能具有多种作用，包括抗病毒和抗炎特性，这可能预防或减轻病毒 URI 的下游后果和心肺后果。
MITIGATE 是一项虚拟的、基于电子健康记录的、开放性标签的、随机的、实用的临床试验，在 Kaiser Permanente Northern California 招募了约 16500 名参与者，这是一个完全整合和学习的医疗保健提供系统，有 21 家医院和超过 255 个门诊诊所，为 450 万成员提供服务。≥50 岁的、有已确诊 ASCVD 病史且无既往 2019 年冠状病毒病（COVID-19）病史的成年人将被前瞻性识别，并以 1:10 的分配比例（IPE：约 15000 名常规治疗）进行预随机分组，分层因素为年龄和既往呼吸道健康状况，分为干预组（IPE 每天两次口服 2 克，随餐服用）和对照组（常规治疗），随访时间至少为 6 个月。主要复合终点是任何时间点实验室确诊的病毒 URI 和因病毒 URI 导致的最差临床状态为中度至重度。
MITIGATE 研究将通过提供关于在高危 ASCVD 患者队列中预先使用 IPE 预防和/或减少实验室确诊病毒 URI 的后遗症的真实世界临床疗效的证据，为临床实践提供信息。
