Status:
COMPLETED
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-120 years
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 cl...
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 re...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Non-valvular atrial fibrillation
Exclusion
- 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 \[Day -180, Day 0\]
Key Trial Info
Start Date :
May 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
353980 Patients enrolled
Trial Details
Trial ID
NCT05256797
Start Date
May 3 2021
End Date
June 15 2022
Last Update
March 4 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120