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GENERAL;GENeral Practitioners and Embolism pRevention in NVAF Patients Treated With RivAroxaban:reaL-life Evidence (GENeRAL)

2015年12月14日更新者：Japan Cardiovascular Research Foundation

Registry Study on the Effectiveness of Rivaroxaban in Patients With Non-valvular Atrial Fibrillation Managed by General Practitioners(GENERAL Study)

In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering this,warfarin is a drug which puts a great burden on patients and medical providers.

With the population aging, the number of non-valvular atrial fibrillation patients is increasing, and a necessity that not only specialist but also general practitioners. Anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly used among general practioners. In such circumstances, Rivaroxaban,a new oral direct factor Xa inhibitor,has become available. Rivaroxaban is administrated once a day and exert an anti- coagulant effect soon after administration. It hardly reacts with foods or other drugs and therefore does not require regular monitoring. GENERAL study is to investigate the effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients when it is prescribed by general practioners in real life settings.

研究概览

地位

未知

条件

心房颤动

研究类型

观察性的

注册 (预期的)

5000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

日本
- Osaka
  - Suita、Osaka、日本、565-8565
    - 招聘中
    - Japan Cardiovascular Research Foundation
    - 接触：
      
      Hisao Ogawa
      
      电话号码：2231 +81-6-6833-5012
      
      邮箱：ogawah@ncvc.go.jp
    - 首席研究员：
      
      Hisao Ogawa, M.D.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

5,000

描述

Inclusion Criteria:

Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners

Exclusion Criteria:

Patients are contraindicated for rivaroxaban
Patients judged as inappropriate for this study by investigators

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Composite of symptomatic stroke (ischemic/hemorrhagic) and systemic embolism 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)

次要结果测量

结果测量	大体时间
Major bleeding events (adapted ISTH standard) 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Non-major bleeding events(without Major Bleeding complications) 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Composite of symptomatic stroke(ischemic or hemorrhagic),systemic embolism,myocardial infarction/unstable angina pectoris and cardiovascular death 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Symptomatic stroke (ischemic or hemorrhagic) 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Symptomatic ischemic stroke 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Symptomatic hemorrhagic stroke 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Systemic embolism 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Acute myocardial infarction/unstable angina pectoris 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Cardiovascular death 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Deep vein thrombosis/pulmonary thromboembolism 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Transient ischemic attack 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Percutaneous coronary intervention /coronary artery bypass grafting 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
All cause death 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Comparison of primary outcome (composite of symptomatic stroke(ischemic/hemorrhagic) and systemic embolism) rate and Major Bleeding complications (adapted ISTH standard)rate between EXPAND study and FUSHIMI AF registry 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Adverse Event excluding hemorrhagic events 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Patients adherence related with stroke or systemic embolism 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)
Correlation with CHADS2 score or other risk factors and outcome events in Japanese patients who administered Rivaroxaban 大体时间：up to 1.5 years(max 3 years)	up to 1.5 years(max 3 years)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Japan Cardiovascular Research Foundation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年9月1日

初级完成 (预期的)

2018年10月1日

研究完成 (预期的)

2018年10月1日

研究注册日期

首次提交

2015年12月9日

首先提交符合 QC 标准的

2015年12月14日

首次发布 (估计)

2015年12月17日

研究记录更新

最后更新发布 (估计)