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Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation (EXPAND)

2014年5月21日更新者：Hiroaki Shimokawa, MD, PhD、Tohoku University

Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Japanese Clinical Practice

The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.

研究概览

地位

未知

条件

非瓣膜性房颤

研究类型

观察性的

注册 (预期的)

7000

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
- Miyagi
  - Sendai、Miyagi、日本、980-6574
    - 招聘中
    - Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
    - 接触：
      
      Koji Fukuda, MD, PhD
      
      电话号码：+81-22-717-7153
      
      邮箱：fukuda@cardio.med.tohoku.ac.jp
    - 首席研究员：
      
      Hiroaki Shimokawa, MD, PhD

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

Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)

描述

Inclusion Criteria:

Patients who meet all the criteria below

Patients aged over 20 years
Patients diagnosed with non-valvular atrial fibrillation
Patients who are treated or will be treated with rivaroxaban
Patients from whom written informed consent has been obtained

Exclusion Criteria:

Patients who meet any of the criteria below

The following patients in whom rivaroxaban is contraindicated for use
Patients with a history of allergies to the ingredients contained in this drug
Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
Patients having renal failure (creatinine clearance: <15 mL/min)
Women who are or are likely to be pregnant
Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))

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

团体/队列数

队列和干预

团体/队列
Non-valvular atrial fibrillation Patients diagnosed with non-valvular atrial fibrillation Patients who are treated or will be treated with rivaroxaban

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism 大体时间：up to March/2016	Primary efficacy endpoint	up to March/2016
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification) 大体时间：up to March/2016	Primary safety endpoint	up to March/2016

次要结果测量

结果测量	措施说明	大体时间
Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Symptomatic ischemic stroke 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Symptomatic hemorrhagic stroke 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Systemic embolism 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Acute myocardial infarction/unstable angina pectoris 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Cardiovascular death 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Deep vein thrombosis/pulmonary thromboembolism 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Transient ischemic attack 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Interventional/surgical treatment 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
All-cause death 大体时间：up to March/2016	Secondary efficacy endpoints	up to March/2016
Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events) 大体时间：up to March/2016	Secondary safety endpoint	up to March/2016

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

Tohoku University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

EXPAND study home page

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

2012年11月1日

初级完成 (预期的)

2016年6月1日

研究注册日期

首次提交

2014年5月12日

首先提交符合 QC 标准的

2014年5月21日

首次发布 (估计)

2014年5月26日

研究记录更新

最后更新发布 (估计)