Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data

NCT ID: NCT05264168

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41875 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2022-06-15

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.

Conditions

Venous Thromboembolism; Pulmonary Embolism; DVT

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Rivaroxaban

Reference group

Rivaroxaban

Intervention Type: DRUG

Any rivaroxaban dispensing claim is used as the reference group

Apixaban

Exposure group

Apixaban

Intervention Type: DRUG

Any apixaban dispensing claim is used as the exposure group

Interventions

Rivaroxaban

Any rivaroxaban dispensing claim is used as the reference group

Intervention Type: DRUG

Apixaban

Any apixaban dispensing claim is used as the exposure group

Intervention Type: DRUG

Other Intervention Names

Xarelto; Eliquis

Eligibility Criteria

Inclusion Criteria

• Hospitalization for PE or Proximal DVT [Day -14, Day 0]
• At least 18 years of age

Exclusion Criteria

• Prior use of a DOAC or warfarin [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]
• Cancer [Day -180, Day 0]
• Bypass surgery, obesity, or the use of a weight loss or appetite suppressor [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]
• Other indications for anticoagulation (atrial fibrillation or prosthetic heart valve) [Day -180, Day 0]
• Pregnancy or breastfeeding [Day -180, Day 0]
• Use of an antiplatelet [Day -180, Day 0]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shirley Vichy Wang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Wang, PhD, ScM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018P002966-DUP-COBRRA-VT

Identifier Type: -

Identifier Source: org_study_id