Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data

Pulmonary Embolism Clinical Trial

Official title:

Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264168
• Other study ID #: 2018P002966-DUP-COBRRA-VT
• Status: Completed
• Start date: May 3, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41875
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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]

Related Conditions & MeSH terms

• DVT
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban
Any rivaroxaban dispensing claim is used as the reference group
• Apixaban
Any apixaban dispensing claim is used as the exposure group

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion or censoring, up to 90 days
Secondary	Relative hazard of major bleeding	Claims-based algorithm: relative hazard of major bleeding	Through study completion or censoring, up to 90 days
Secondary	Relative hazard of clinically relevant non-major bleeding	Claims-based algorithm: relative hazard of clinically relevant non-major bleeding	Through study completion or censoring, up to 90 days
Secondary	Relative hazard of all-cause mortality	Claims-based algorithm: relative hazard of all-cause mortality	Through study completion, up to 90 days
Secondary	Relative hazard of recurrent VTE	Claims-based algorithm: relative hazard of recurrent VTE	Through study completion, up to 90 days
Secondary	Relative hazard of extracranial bleeding	Claims-based algorithm: relative hazard of extracranial bleeding	Through study completion, up to 90 days
Secondary	Relative hazard of intracranial bleeding	Claims-based algorithm: relative hazard of intracranial bleeding	Through study completion, up to 90 days