Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data

NCT05256797 | Completed Results FDA Drug

• 1 other identifier: 2018P002966-DUP-COBRRA-AF
• Study Type: observational
• Target: 353,980
• 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding Events

  Claims-based algorithm: incidence of major bleeding or clinically relevant non-major bleeding events

  Through study completion or censoring, up to 365 days

Secondary Outcomes (6)

• Incidence of Major Bleeding

  Through study completion or censoring, up to 365 days

• Incidence of Clinically Relevant Non-major Bleeding

  Through study completion or censoring, up to 365 days

• Incidence of All-cause Mortality

  Through study completion or censoring, up to 365 days

• Incidence of Stroke

  Through study completion or censoring, up to 365 days

• Incidence of Extracranial Bleeding

  Through study completion or censoring, up to 365 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 with non-valvular atrial fibrillation.

You may qualify if:

• At least 18 years of age
• Non-valvular atrial fibrillation

You may not qualify if:

• 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 \[Day -180, Day 0\]

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

Atrial Fibrillation

Interventions

Rivaroxaban; apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shirley Wang
• Organization: Brigham and Women's Hospital

swang1@bwh.harvard.edu

617-525-8376

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 16, 2022
• First Posted: February 25, 2022
• Study Start: May 3, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (1)