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首页> 外文期刊>Journal of arrhythmia. >Study design of GENERAL (general practitioners and embolism prevention in NVAF patients treated with rivaroxaban: Real-life evidence): A multicenter prospective cohort study in primary care physicians to investigate the effectiveness and safety of rivaroxaban in Japanese patients with NVAF
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Study design of GENERAL (general practitioners and embolism prevention in NVAF patients treated with rivaroxaban: Real-life evidence): A multicenter prospective cohort study in primary care physicians to investigate the effectiveness and safety of rivaroxaban in Japanese patients with NVAF

机译：一般的研究设计（普通人患者中的一般从业者和栓塞预防，所述Rivaroxaban治疗：现实实践证据）：初级护理医师的多中心前瞻性队列研究，探讨日本NVAF患者Rivaroxaban的有效性和安全性

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Background: Rivaroxaban, a direct oral anticoagulant (DOAC), has become available for stroke prevention in patients with non-valular atrial fibrillation (NVAF). However, little is known about its effectiveness and safety when prescribed by general practitioners in real-life settings. Methods: GENERAL is a multicenter, prospective, non-interventional observational study of patients receiving rivaroxaban for NVAF in daily clinical practice prescribed specifically by general practitioners. The target number of participating medical institutions is 500-700 clinics with fewer than 20 beds and the target number of participants is 5000. The baseline clinical data, including antidementia medication and frailty, and follow-up data including concomitant treatment and outcomes until September 2018 (maximum three years) will be collected. The primary efficacy endpoints will be stroke and/or systemic embolism and the secondary endpoints will be major bleeding meeting the ISTH guidelines, non-major and clinically relevant bleeding, onset of symptomatic stroke (ischemic/hemorrhagic), systemic embolism, deep vein thrombosis/pulmonary thromboembolism, myocardial infarction and/or cardiovascular death, and systemic embolism. Based on the provided information, the event assessment committee will investigate the endpoint-related events. The annual incidence and predictive factors for primary/secondary endpoint will be investigated based on underlying disease, age, renal function, and CHADS"2, CHA"2DS"2-VASC, and HAS-BLED scores using Cox regression. We will also compare the incidence of the primary/secondary endpoint between the present study, EXPAND study, and FUSHIMI AF registry study. Results: The results of this study are currently under investigation. Conclusion: This study will provide important information regarding the effectiveness and safety of rivaroxaban treatment in Japanese patients with NVAF among general practitioners.
机译：背景：Rivaroxaban是一种直接口服抗凝血剂（DOAC），已经可用于患有非隙性心房颤动（NVAF）的患者中风预防。然而，在现实生活中的一般从业者规定时，对其有效性和安全性很少。方法：一般是一般从业公司专门专门规定的日常临床实践中接受NVAF患者的多中心，前瞻性，非介入的观察性研究。参与医疗机构的目标数量是500-700张床单，床单少于20张，参与者的目标数量为5000.基线临床数据，包括防水药物和脆弱，以及后续数据，包括伴随治疗和结果，直到2018年9月到9月（最多三年）将收集。初级疗效终点将是卒中和/或全身栓塞，次要终点将主要出血，符合ISTH准则，非专业和临床相关的出血，发病症状中风（缺血性/出血），全身栓塞，深静脉血栓形成/肺血栓栓塞，心肌梗死和/或心血管死亡和全身栓塞。根据提供的信息，活动评估委员会将调查与终点相关的事件。初级/次级终点的年发病率和预测因素将根据潜在的疾病，年龄，肾功能和乍得“2，CHA”2DS“2-VASC，以及使用COX回归的BLED分数。我们也将比较本研究，扩展研究和Fushimi AF注册表研究中主要/次要终点的发病率。结果：本研究的结果目前正在调查中。结论：本研究将提供有关Rivaroxaban治疗的有效性和安全性的重要信息在日本患有全科医生中的NVAF患者。

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