NCT02546817已完成不适用
Eliquis (Apixaban) Regulatory Postmarketing Surveillance In Real World Practice (rPMS) For Venous Thromboembolism (VTE) Treatment And Prevention Of Recurrent VTE
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Patient characteristics that are associated with bleeding among patients taking Eliquis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient characteristics that are associated with bleeding among patients taking Eliquis
时间窗: Approximately 2 years
Patient Characteristics: Age, sex, weight, height, baseline blood pressure, baseline serum creatinine, baseline creatinine clearance, and device insertion history
Safety of Eliquis in Korean VTE patients based on incidence of adverse events (AEs), serious adverse events (SAEs)
时间窗: Approximately 2 years
次要结局
- Effectiveness of Eliquis in Korean VTE patients based on proportion of patients with no evidence of VTE and occurrence of VTE(Approximately 2 years)
研究者
研究点 (1)
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