NCT01885598已完成不适用
Eliquis (Apixaban) Regulatory Postmarketing Surveillance in Clinical Practice for Stroke Prevention in Nonvalvular Atrial Fibrillation
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3,335 人开始时间: 2013年7月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,335
- 试验地点
- 1
- 主要终点
- Adverse events (AE) occurrence based on Incidence of serious adverse events, unexpected adverse drug reactions, Identification of AE profile in usual practice Nonserious adverse events, major bleeding
研究概览
简要总结
The primary objective of this study is to examine the safety profile of Eliquis in Korean nonvalvular atrial fibrillation 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
- •Patients ≥19 years of age
- •Adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating Eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism
- •Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
排除标准
- •Receiving Eliquis treatment for an indication that is not approved in Korea
- •Contraindicated for the use of Eliquis as described in the Korean label
研究组 & 干预措施
Nonvalvular Atrial Fibrillation patients with risk of Stroke
Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty and signed on the data release
干预措施: Apixaban (Drug)
结局指标
主要结局
Adverse events (AE) occurrence based on Incidence of serious adverse events, unexpected adverse drug reactions, Identification of AE profile in usual practice Nonserious adverse events, major bleeding
时间窗: within 30 days after end of the treatment
次要结局
- Final identification of major events and no event based on Incidence of stroke, systemic embolism, death, Effectiveness or death at 24 months after discontinuation of therapy or at the end of the observation period (whatever is later)(At 3, 6, 12, and 24 months after enrollment)
- Final evaluation of clinical significance of Eliquis is provided by the physician's subjective decision (Excellent, Good, Moderate, Insufficient)(At 3, 6, 12, and 24 months after enrollment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMSVenous ThromboembolismNCT02546817Bristol-Myers Squibb29
已完成
不适用
Eliquis Regulatory Post Marketing Surveillance (rPMS)Venous ThromboembolismNCT01885585Bristol-Myers Squibb100
已完成
不适用
ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTEVenous ThromboembolismNCT02836457Bristol-Myers Squibb1,134
已完成
不适用
ABF Tourette's Disorder Post Marketing Surveillance StudyTourette's DisorderNCT01795105Korea Otsuka Pharmaceutical Co., Ltd.692
已完成
不适用
Early Post-Marketing Study of ELIQUIS (Apixaban) in MexicoDeep Vein ThrombosisPulmonary EmbolismNCT02345343Bristol-Myers Squibb100