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Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS

2017年10月27日 更新者:Bristol-Myers Squibb

Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE

To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis. To identify factors that might be associated with the safety and effectiveness profile in Korean VTE patients.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

29

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

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

19年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time

描述

Inclusion Criteria:

  • Adult (≥19 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study

Exclusion Criteria:

  • Patients with prior treatment with Eliquis before enrollment in this study
  • Patients receiving Eliquis treatment for an indication not approved indication in Korea
  • Patients meeting any of the following criteria will not be included in the study:

    i) Hypersensitivity to the active substance or to any of the excipients

ii) Clinically significant active bleeding

iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk

iv) Patients with increased bleeding risk due to such as following diseases:

  1. Recent gastrointestinal ulceration history
  2. Recent intracranial or intracerebral haemorrhage history
  3. Intraspinal or intracerebral vascular abnormalities
  4. Recent brain, spinal or ophthalmic surgery history
  5. Recent brain or spinal injury
  6. Known or suspected oesophageal varices
  7. Arteriovenous malformations
  8. Vascular aneurysms
  9. Patients with malignant neoplasms at high risk of bleeding

    • Concomitant treatment with any other anticoagulant agent:

i) Unfractionated heparin (UFH)

ii) Low molecular weight heparins (enoxaparin, dalteparin, etc)

iii) Heparin derivatives (fondaparinux, etc)

iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter

  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption

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:仅案例
  • 时间观点:预期

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
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
大体时间:Approximately 2 years
Approximately 2 years
Patient characteristics that are associated with bleeding among patients taking Eliquis
大体时间:Approximately 2 years
Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history
Approximately 2 years

次要结果测量

结果测量
措施说明
大体时间
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
大体时间:Approximately 2 years

For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The incidence proportion will be estimated

For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The incidence proportion will be estimated

Approximately 2 years
Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE
大体时间:Approximately 2 years

For VTE treatment: The proportion of patients with recurrent VTE at 24 weeks will be calculated. The 95% confidence intervals will be estimated

For prevention of recurrent VTE: The proportion of patients with recurrent VTE at 24 weeks, 52 weeks, and 104 weeks, will be calculated. The 95% confidence intervals will be estimated

Approximately 2 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。

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)

2015年11月30日

初级完成 (实际的)

2017年9月29日

研究完成 (实际的)

2017年9月29日

研究注册日期

首次提交

2015年9月7日

首先提交符合 QC 标准的

2015年9月9日

首次发布 (估计)

2015年9月11日

研究记录更新

最后更新发布 (实际的)

2017年10月31日

上次提交的符合 QC 标准的更新

2017年10月27日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CV185-440

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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