Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 209
- 主要终点
- Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban
研究概览
简要总结
This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥ 18 years old who start treatment with rivaroxaban
- •Non-valvular Atrial Fibrillation is documented in patients' file
- •Prior TIA/Stroke history
- •TIA - more than 72 hours after documented TIA
- •more than 2 weeks after non-hemorrhagic stroke
- •Written informed consent
排除标准
- •Contraindications for use of Xarelto® in accordance with approved product label
- •Previous thromboprophylaxis treatment with anticoagulants prior toby reason of stroke / TIA prevention
- •Any reasons of medical and non-medical character, which in the opinion of the physician can hamper patient participation in NIS
结局指标
主要结局
Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban
时间窗: up to 6 months
* Time lag after prior stroke or TIA before Xarelto prescription; * Frequency of switching/discontinuation of Xarelto treatment; * Time to switching/discontinuation of Xarelto treatment; * Reasons of switching/discontinuation of Xarelto treatment (using formalized criteria list); * In case of change of treatment - drug, dose, duration of use
次要结局
- Descriptive characteristics of patients after prior stroke/TIA in the need of secondary stroke prevention with Xarelto (gender, age, race, alcohol/smoking, BMI and BP abnormalities, CHA2DS2 VASC, HAS BLED, Rankin Score)(up to 6 months)
- Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practice(up to 6 months)
- Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)(up to 6 months)