Comparative Effectiveness and Safety Between Warfarin and Dabigatran
2019年7月4日 更新者：Boehringer Ingelheim
Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin.
There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
研究概览
详细说明
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin.
There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
研究类型
观察性的
注册 (实际的)
22490
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
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Tokyo、日本
- Nippon Boehringer Ingelheim Co., Ltd.
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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
18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
非概率样本
研究人群
Any patients with atrial fibrillation contained in the Medical Data Vision (MDVI) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively.
The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.
描述
Inclusion Criteria:
- patients aged >18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)
- having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016
- having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)
Exclusion Criteria:
- patients having less than 12 months of enrolment prior to the index date
- being dialysis or kidney transplant recipients in baseline period
- having either atrial flutter, valvular atrial fibrillation (AF)
- mechanical valve placement, rheumatic AF
- and/or mitral valve prolapse/regurge/stenosis in baseline period
- having record of deep vein thrombosis or pulmonary embolism < 6 months before AF diagnosis in baseline period
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Atrial Fibrillation
patients with atrial fibrillation
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patients treated with warfarin
patients treated with Dabigatran
其他名称：
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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 |
|---|---|---|
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Incidence Rate of Stroke and Systemic Embolism (SE)
大体时间：From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
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Incidence rate of stroke and systemic embolism (SE).
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From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence Rate of Major Bleeding
大体时间：From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.
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Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
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From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 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。
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
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 (实际的)
2017年10月20日
初级完成 (实际的)
2017年10月30日
研究完成 (实际的)
2017年11月3日
研究注册日期
首次提交
2017年8月17日
首先提交符合 QC 标准的
2017年8月17日
首次发布 (实际的)
2017年8月18日
研究记录更新
最后更新发布 (实际的)
2019年7月9日
上次提交的符合 QC 标准的更新
2019年7月4日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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