Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS
Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Seoul、大韩民国
- Local Institution
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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:
- Recent gastrointestinal ulceration history
- Recent intracranial or intracerebral haemorrhage history
- Intraspinal or intracerebral vascular abnormalities
- Recent brain, spinal or ophthalmic surgery history
- Recent brain or spinal injury
- Known or suspected oesophageal varices
- Arteriovenous malformations
- Vascular aneurysms
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
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
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Approximately 2 years
|
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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
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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