Deep Vein Thrombosis, Pulmonary Embolus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGRivaroxaban
Initiation of rivaroxaban described in electronic health records is used as the exposure.
DRUGEnoxaparin
Initiation of enoxaparin described in electronic health records is used as the reference.
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 17 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShirley Wang, PhD, ScM
Brigham and Women's Hospital
Outcome results
None listed