Replication of the EINSTEIN-PE Anticoagulant Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98,947
- 试验地点
- 1
- 主要终点
- Relative hazard of recurrent venous thromboembolic events
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
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
- •Confirmed acute symptomatic proximal PE with or without symptomatic DVT
排除标准
- •Legal lower age limitations [Day 0, Day 0]
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE [Day -14, Day 0]
- •Other indications for VKA than DVT and/or PE [Day -180, Day 0]
- •Creatinine clearance <30 ml/min [Day -180, Day 0]
- •Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT>3x ULN [Day -180, Day 0]
- •Bacterial endocarditis [Day -180, Day 0]
- •Life expectancy <3 months [Day -365, Day 0]
- •Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA [Day -180, Day 0]
- •Systolic blood pressure >180 mgHg or diastolic blood pressure >110mgHg [Day -180, Day 0]
- •Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding [Day -180, Day 0]
- •Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers rifampin [Day -14, Day 0]
研究组 & 干预措施
Warfarin
Reference group
干预措施: Warfarin (Drug)
Rivaroxaban
Exposure group
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Relative hazard of recurrent venous thromboembolic events
时间窗: Through study completion or censoring, up to 12 months
Claims-based algorithm: see attached protocol for full definition
次要结局
- Relative hazard of major bleeding(Through study completion or censoring, up to 12 months)
研究者
Shirley Vichy Wang
Assistant Professor
Brigham and Women's Hospital