Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 812
- 试验地点
- 1
- 主要终点
- Date of start of rivaroxaban treatment
研究概览
简要总结
While it is well known that stopping or changing medication with blood thinners in patients who suffer from non-valvular atrial fibrillation (NVAF) increases the risk of ischemic stroke (a condition which occurs when a vessel supplying blood to the brain is obstructed), bleeding or thromboembolism (a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel), limited data are available on the number of NVAF patients and the reasons why NVAF patients in Italy stop or change their treatment with blood thinners to prevent stroke or thromboembolism.
By following the NVAF patients in routine clinical practice in Italy who are treated with rivaroxaban to prevent stroke or systemic embolism researchers want to find out how many NVAF patients and for what reasons NVAF patients stopped or changed rivaroxaban treatment. Study data will be collected through patients' routine visits at their treating doctor over a period of 24 months for each patient.
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
- •Age >= 18
- •Patient with a diagnosis of NVAF
- •New user to rivaroxaban, naïve or non naïve to treatment with oral anticoagulant
- •Patient for whom the decision to initiate treatment with rivaroxaban was made as per physician's routine treatment practice for prevention of stroke and non-central nervous system (CNS) systemic embolism
- •Signed an informed consent
排除标准
- •Patient with heart valve replacement
- •Patient is participating in an investigational program with interventions outside of routine clinical practice
研究组 & 干预措施
NVAF patients
Start treatment with rivaroxaban at the discretion of physician.
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Date of start of rivaroxaban treatment
时间窗: 24 months
Date of stop of rivaroxaban treatment
时间窗: 24 months
Number of patients who discontinue (i.e: number of discontinuation) from study initiation to end of observation/follow up.
时间窗: 24 months
次要结局
- Reason for switch to other therapy(24 months)
- Reasons for discontinuation of rivaroxaban therapy(24 months)
- Reason for dose change of rivaroxaban therapy(24 months)
- Treatment adherence: Self-reported medication adherence measured by the MMAS-8 (Morinsky Scale score)(24 months)