Emulation of the RECORD3 Trial Using Healthcare Claims Data
2026年7月8日 更新者：Shirley Vichy Wang、Brigham and Women's Hospital
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
149248
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02120
- Brigham and Women's Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients aged 18 years or older undergoing elective total knee arthroplasty.
描述
Inclusion Criteria:
- At least 18 years of age
- Scheduled to undergo elective total knee replacement
Exclusion Criteria:
- Pregnancy or breastfeeding
- Had active bleeding or high risk of bleeding
- Had contraindications for prophylaxis with enoxaparin
- Drug or alcohol abuse
- Concomitant use of protease inhibitors for the treatment of HIV
- Had planned intermittent pneumatic compression
- Had a requirement for anticoagulant therapy that could not be stopped
- Substantial liver disease
- Severe renal impairment (creatinine clearance <30 ml per minute)
- Concurrent use of both drugs
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
利伐沙班
曝光组
|
Initiation of rivaroxaban described in electronic health records is used as the exposure.
其他名称：
|
|
依诺肝素
参照组
|
Initiation of enoxaparin described in electronic health records is used as the reference.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 17 days
大体时间：From 1 day after fill until earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 17 days.
|
The primary outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of any component of the composite endpoint: deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 17 days after elective total knee arthroplasty, comparing rivaroxaban versus enoxaparin.
|
From 1 day after fill until earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 17 days.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to first occurrence of fracture or fall
大体时间：From 1 day after fill until earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 17 days.
|
The outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of fracture or fall as a control outcome, comparing rivaroxaban versus enoxaparin.
|
From 1 day after fill until earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 17 days.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shirley Wang, PhD, ScM、Brigham and Women's Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年10月13日
初级完成 (实际的)
2026年6月15日
研究完成 (实际的)
2026年6月15日
研究注册日期
首次提交
2026年5月14日
首先提交符合 QC 标准的
2026年5月14日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.