An observational study in Venous Thromboembolism, Pulmonary Embolism and DVT, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 41,875 is above the median of 392 across 324 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism 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 apixaban users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or apixaban (index date). Analysis is restricted to patients hospitalized with a VTE.
Exclusion Criteria:
Reference group
Drug: Rivaroxaban
Exposure group
Drug: Apixaban
Any rivaroxaban dispensing claim is used as the reference group
Also known as: Xarelto
Any apixaban dispensing claim is used as the exposure group
Also known as: Eliquis
Relative hazard of major bleeding or clinically relevant non-major bleeding events
Claims-based algorithm: relative hazard of major bleeding or clinically relevant non-major bleeding events
Time frame: Through study completion or censoring, up to 90 days
Relative hazard of major bleeding
Claims-based algorithm: relative hazard of major bleeding
Time frame: Through study completion or censoring, up to 90 days
Relative hazard of clinically relevant non-major bleeding
Claims-based algorithm: relative hazard of clinically relevant non-major bleeding
Time frame: Through study completion or censoring, up to 90 days
Relative hazard of all-cause mortality
Claims-based algorithm: relative hazard of all-cause mortality
Time frame: Through study completion, up to 90 days
Relative hazard of recurrent VTE
Claims-based algorithm: relative hazard of recurrent VTE
Time frame: Through study completion, up to 90 days
Relative hazard of extracranial bleeding
Claims-based algorithm: relative hazard of extracranial bleeding
Time frame: Through study completion, up to 90 days
Relative hazard of intracranial bleeding
Claims-based algorithm: relative hazard of intracranial bleeding
Time frame: Through study completion, up to 90 days
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital