NCT03521908已完成不适用
Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 35,756 人开始时间: 2016年6月13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
- 35,756
- 试验地点
- 1
- 主要终点
- Incidence of major bleeding in participants treated with apixaban
研究概览
简要总结
A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
- •An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
- •Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter
排除标准
- •Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
- •Evidence of VTE(VTE event)during 6-month period preceding index encounter
- •Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of major bleeding in participants treated with apixaban
时间窗: 2 years
Incidence of major bleeding in participants treated with warfarin
时间窗: 2 years
次要结局
- Incidence of clinically relevant non-major bleeding event in participants treated with apixaban(2 years)
- Incidence of recurrent VTE in participants treated with warfarin(2 years)
- Incidence of clinically relevant non-major bleeding event in participants treated with warfarin(2 years)
- Incidence of recurrent VTE in participants treated with apixaban(2 years)
研究者
研究点 (1)
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