Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353,980
- 试验地点
- 1
- 主要终点
- Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Non-valvular atrial fibrillation
排除标准
- •Prior anticoagulant use [Day -180, Day 0]
- •Stage 4 or 5 chronic kidney disease or end-stage renal disease [Day -180, Day 0]
- •Dialysis or renal transplant [Day -180, Day 0]
- •Recent major or clinically relevant non-major bleeding [Day -180, Day 0]
- •Other indications for anticoagulation (DVT, PE, or prosthetic heart valve) [Day -180, Day 0]
- •Use of an antiplatelet [Day -180, Day 0]
- •Significant liver disease and coagulopathy [Day -180, Day 0]
- •Use of CYP3A4 or P-gp inhibitors or inducers [Day -180, Day 0]
- •Pregnancy or breastfeeding [Day -180, Day 0]
- •Cancer [Day -180, Day 0]
- •Bypass surgery, obesity, or the use of a weight loss or appetite suppressor [Day -180, Day 0]
- •Mitral stenosis with or without insufficiency, mitral rheumatic insufficiency, and other/unspecified mitral valve disorders [Day -180, Day 0]
研究组 & 干预措施
Rivaroxaban
Reference group
干预措施: Rivaroxaban (Drug)
Apixaban
Exposure group
干预措施: Apixaban (Drug)
结局指标
主要结局
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding Events
时间窗: Through study completion or censoring, up to 365 days
Claims-based algorithm: incidence of major bleeding or clinically relevant non-major bleeding events
次要结局
- Incidence of Major Bleeding(Through study completion or censoring, up to 365 days)
- Incidence of Clinically Relevant Non-major Bleeding(Through study completion or censoring, up to 365 days)
- Incidence of All-cause Mortality(Through study completion or censoring, up to 365 days)
- Incidence of Stroke(Through study completion or censoring, up to 365 days)
- Incidence of Extracranial Bleeding(Through study completion or censoring, up to 365 days)
- Incidence of Intracranial Bleeding(Through study completion or censoring, up to 365 days)
研究者
Shirley Vichy Wang
Associate Professor
Brigham and Women's Hospital