Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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]

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban	Reference group
Apixaban	Apixaban	Exposure group

Primary Outcome Measures

Name	Time	Method
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding Events	Through study completion or censoring, up to 365 days	Claims-based algorithm: incidence of major bleeding or clinically relevant non-major bleeding events

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Bleeding	Through study completion or censoring, up to 365 days	Claims-based algorithm: Incidence of major bleeding
Incidence of Clinically Relevant Non-major Bleeding	Through study completion or censoring, up to 365 days	Claims-based algorithm: Incidence of clinically relevant non-major bleeding
Incidence of All-cause Mortality	Through study completion or censoring, up to 365 days	Claims-based algorithm: Incidence of all-cause mortality
Incidence of Stroke	Through study completion or censoring, up to 365 days	Claims-based algorithm: Incidence of stroke
Incidence of Extracranial Bleeding	Through study completion or censoring, up to 365 days	Claims-based algorithm: Incidence of extracranial bleeding (any position)
Incidence of Intracranial Bleeding	Through study completion or censoring, up to 365 days	Claims-based algorithm: Incidence of intracranial bleeding (any position)