Real-world Dosing Patterns of Rivaroxaban in the United States (RIVA-D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 12,507
- 主要终点
- Number of NVAF patients receiving 20 mg Rivaroxaban
研究概览
简要总结
The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban.
The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal function).
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 International Classification of Disease ICD-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
- •Evidence of continuous enrollment in MarketScan during 180 days before the date of the first prescription of rivaroxaban
排除标准
- •Patients <18 years of age
- •Patients with valvular AF (atrial fibrillation)
- •Pregnancy
- •Malignant cancers
- •Transient cause of AF
- •Patients with VTE (Venous thromboembolism), pulmonary embolism or DVT (Deep Vein Thrombosis)
- •Patients with major surgery defined as hip or knee replacement
- •Prescriptions of OACs (Oral anticoagulants) (apixaban,warfarin, dabigatran, rivaroxaban) before index date
- •Prescription of more than one OAC on the index date
研究组 & 干预措施
NVAF patients receiving 20 mg rivaroxaban
NVAF patients who receive a standard dose of rivaroxaban (20 mg daily)
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
NVAF patients receiving 15 mg rivaroxaban
NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily)
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Number of NVAF patients receiving 20 mg Rivaroxaban
时间窗: At baseline
Number of NVAF patients receiving 15 mg Rivaroxaban
时间窗: At baseline
次要结局
- Baseline renal function(At baseline)