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首页> 外文期刊>Clinical cardiology. >Design and rationale of the EBBINGHAUS trial: A phase 3, double‐blind, placebo‐controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid‐lowering therapy—A cognitive study of patients enrolled in the FOURIER trial
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Design and rationale of the EBBINGHAUS trial: A phase 3, double‐blind, placebo‐controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid‐lowering therapy—A cognitive study of patients enrolled in the FOURIER trial

机译：EBBINGHAUS试验的设计和原理：一项三阶段，双盲，安慰剂对照，多中心研究，评估依维洛单抗对临床上明显的心血管疾病并接受他汀类降脂治疗的患者认知功能的影响-一项认知研究参加FOURIER试验的患者

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Abstract Some observational studies raised concern that statins may cause memory impairment, leading to a US Food and Drug Administration warning. Similar questions were raised regarding proprotein convertase subtilisin/kexin-type 9 inhibitors (PCSK9i) and neurocognitive function. No prospectively designed study has evaluated the relationship between long-term PCSK9i use and cognition changes. Patients with prior cardiovascular disease treated with maximally tolerated statin enrolled in FOURIER (the randomized, double-blind, placebo-controlled cardiovascular outcome study of the PCSK9i evolocumab) could participate in this prospective assessment of cognitive function (EBBINGHAUS). Key additional exclusion criteria for EBBINGHAUS were dementia, cognitive impairment, or other significant mental or neurological disorder. Cognitive testing was performed using the Cambridge Neuropsychological Test Automated Battery, a tablet-based tool assessing executive function, working memory, memory function, and psychomotor speed at baseline, weeks 24 and 48, every 48 weeks thereafter, and study end. The primary endpoint was spatial working memory strategy index of executive function (SWMSI). The primary hypothesis was that evolocumab would be noninferior to placebo in the mean change from baseline over time in SWMSI. Fifteen hundred cognitively normal patients completing the assessments provided approximately 97% power to demonstrate that the upper 95% confidence interval for the treatment difference in mean change from baseline in SWMSI over time is
机译：摘要一些观察性研究引起了人们的关注，他汀类药物可能会导致记忆障碍，从而导致美国食品和药物管理局警告。关于前蛋白转化酶枯草杆菌蛋白酶/ kexin型9抑制剂（PCSK9i）和神经认知功能也提出了类似的问题。没有前瞻性设计的研究评估了长期使用PCSK9i与认知变化之间的关系。在FOURIER（PCSK9i evolocumab的随机，双盲，安慰剂对照心血管结果研究）中接受最大耐受他汀类药物治疗的先前患有心血管疾病的患者可以参加这项认知功能的前瞻性评估（EBBINGHAUS）。 EBBINGHAUS的其他主要排除标准是痴呆，认知障碍或其他严重的精神或神经疾病。认知测试是使用Cambridge Neuropsychological Test Automated Battery进行的，这是一种基于平板电脑的工具，在基线，第24周和第48周，此后每48周以及研究结束时评估执行功能，工作记忆，记忆功能和精神运动速度。主要终点是执行功能的空间工作记忆策略指数（SWMSI）。主要假设是，在SWMSI中，随着时间的推移，evolocumab与基线相比的平均变化将不逊于安慰剂。 1,500名完成评估的认知正常患者提供了大约97％的功效，证明了随着时间的推移，SWMSI与基线相比平均变化的治疗差异的上限95％置信区间为

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