An observational study in Venous Thromboembolism, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Brigham and Women's Hospital · Observational
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.
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.
694 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.
This study's enrollment of 78,605 is above the median of 700 across 283 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT without symptomatic PE.
Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Inclusion Criteria:
- Confirmed acute symptomatic proximal DVT without symptomatic PE
Exclusion Criteria:
Any of the following six months prior to and including day of enrollment:
Reference group
Drug: Warfarin
Exposure group
Drug: Rivaroxaban
Rivaroxaban dispensing claim is used as the exposure group
Warfarin dispensing claim is used as the reference group
Time to first occurrence of venous thromboembolism
The primary outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of venous thromboembolism up to 1 year
Time frame: From 1 day after prescription fill until outcome occurrence or censoring due to end of follow-up, death, treatment discontinuation, nursing home admission, treatment augmentation, or switch to another NOAC, assessed up to 1 year.
Time to first occurrence of major bleeding
The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of a major bleeding event as a control outcome up to 1 year
Time frame: From 1 day after prescription fill until outcome occurrence or censoring due to end of follow-up, death, treatment discontinuation, nursing home admission, treatment augmentation, or switch to another NOAC, assessed up to 1 year.
Time to first occurrence of fracture or fall
The control 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 up to 1 year
Time frame: From 1 day after prescription fill until outcome occurrence or censoring due to end of follow-up, death, treatment discontinuation, nursing home admission, treatment augmentation, or switch to another NOAC, assessed up to 1 year.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital