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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.
Journal of Arrhythmia 2017 August
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 CHADS2, CHA2DS2-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.
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 CHADS2, CHA2DS2-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.
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