NCT02690155已完成不适用
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 38,831
- 主要终点
- Incidence of Hospitalization Events (composite endpoint)
研究概览
简要总结
To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
- •Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
- •CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)
排除标准
- •Patients <18 years of age
- •Patients with valvular AF (Atrial fibrillation)
- •Pregnancy
- •Malignant cancers
- •Transient cause of AF
- •Patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis)
- •Patients with major surgery defined as hip or knee replacement
- •Prescriptions of oral anticoagulants (OACs) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
- •Prescription of more than one OAC on the index date
- •Patient with any of the events defined in the composite endpoint
- •Fatal bleeding
- •Fatal Stroke/Myocardial infarction
- •Intracranial hemorrhage
- •Ischemic stroke
- •Myocardial infarction
研究组 & 干预措施
Rivaroxaban
NVAF patients who were initiated on rivaroxaban for stroke prevention
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
VKA (Vitamin K antagonist)
NVAF patients who were initiated on VKA for stroke prevention
干预措施: VKA (Vitamin K antagonist) (Drug)
结局指标
主要结局
Incidence of Hospitalization Events (composite endpoint)
时间窗: Within 2 years of starting treatment
次要结局
未报告次要终点
研究者
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撤回
4 期
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