此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

2015年7月1日 更新者：Boehringer Ingelheim

The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

研究概览

地位

完全的

条件

详细说明

Study Design:

Retrospective

研究类型

观察性的

注册 (实际的)

25586

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

  • 美国
    • Massachusetts
      • Lexington、Massachusetts、美国
        • 1160.183.01 Boehringer Ingelheim Investigational Site

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

NVAF

描述

Inclusion criteria:

  • Patients must be continuously enrolled in a health plan during the pre-index period;
  • Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
  • Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
  • Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
  • Aged 18-89 on the index date;

Exclusion criteria:

  • Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
  • Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

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

  • 时间观点：追溯

队列和干预

团体/队列
达比加群酯
华法林

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
Stroke (Hemorrhagic, Ischemic)
大体时间：From October 1, 2009 through July 31, 2013 (the study period)

Event rate of stroke (hemorrhagic, ischemic).

Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period)
Major Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period)

Event rate of major bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period)

次要结果测量

结果测量
措施说明
大体时间
Ischemic Stroke
大体时间：From October 1, 2009 through July 31, 2013 (the study period)

Event rate of ischemic stroke.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period)
Hemorrhagic Stroke
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of hemorrhagic stroke.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Intracranial Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major intracranial bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Extracranial Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major extracranial bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major GI Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major gastrointestinal (GI) bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Upper GI Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major upper gastrointestinal (GI) bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Lower GI Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major lower gastrointestinal (GI) bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Urogenital Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major urogenital bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Major Other Bleeding
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of major other bleeding.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Transient Ischemic Attack
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of transient ischemic attacks.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Myocardial Infarction
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of myocardial infarction.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Venous Thromboembolism
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of venous thromboembolism.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Deep Vein Thrombosis
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of deep vein thrombosis.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Pulmonary Embolism
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of pulmonary embolism.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).
Death
大体时间：From October 1, 2009 through July 31, 2013 (the study period).

Event rate of death, due to any cause.

The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.
From October 1, 2009 through July 31, 2013 (the study period).

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

Boehringer Ingelheim

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

2014年1月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2014年1月10日

首先提交符合 QC 标准的

2014年1月21日

首次发布 (估计)

2014年1月23日

研究记录更新

最后更新发布 (估计)

2015年7月3日

上次提交的符合 QC 标准的更新

2015年7月1日

最后验证

2015年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1160.183

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.

订阅