Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data

NCT05264168 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-COBRRA-VT
• Study Type: observational
• Target: 41,875
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Pulmonary Embolism; DVT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Relative hazard of major bleeding

  Through study completion or censoring, up to 90 days

• Relative hazard of clinically relevant non-major bleeding

  Through study completion or censoring, up to 90 days

• Relative hazard of all-cause mortality

  Through study completion, up to 90 days

• Relative hazard of recurrent VTE

  Through study completion, up to 90 days

• Relative hazard of extracranial bleeding

  Through study completion, up to 90 days

Study Arms (2)

Rivaroxaban

Reference group

Drug: Rivaroxaban

Apixaban

Exposure group

Drug: Apixaban

Interventions

Rivaroxaban DRUG

Any rivaroxaban dispensing claim is used as the reference group

Also known as: Xarelto

Rivaroxaban

Apixaban DRUG

Any apixaban dispensing claim is used as the exposure group

Also known as: Eliquis

Apixaban

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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 \[Day -180, Day 0\]

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism

Interventions

Rivaroxaban; apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: May 3, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)