A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
研究概览
简要总结
To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years outpatient (regardless of sex)
- •Patients diagnosed as non-valvular atrial fibrillation (NVAF)
- •One or more following risks of stroke.
排除标准
- •Recent cerebral infarction (includes TIA) within 4 weeks of week
- •Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
- •Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
研究组 & 干预措施
Apixaban 5mg BID
干预措施: Apixaban (Drug)
Apixaban 2.5mg BID
干预措施: Apixaban (Drug)
Warfarin
干预措施: Warfarin sodium (Drug)
结局指标
主要结局
Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
时间窗: Baseline to Week 12
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
次要结局
- Number of Participants With Total Bleeding Events During the Treatment Period(Baseline to Week 12)
- Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period(Baseline to Week 12)
- Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period(Baseline to Week 12)
- Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period(Baseline to Week 12)
- Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period(Baseline to Week 12)
- Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period(Baseline to Week 12)