N/A
N=353,980
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT05256797 ↗Enrolled (actual)
353,980
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding Events — 9.2; 6.4 No. of new events per 100 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rivaroxaban (Drug); Apixaban (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding Events |
9.2; 6.4 | — |
| SECONDARY Incidence of Major Bleeding |
4.0; 2.4 | — |
| SECONDARY Incidence of Clinically Relevant Non-major Bleeding |
8.7; 5.9 | — |
| SECONDARY Incidence of All-cause Mortality |
2.7; 2.4 | — |
| SECONDARY Incidence of Stroke |
1.1; 0.9 | — |
| SECONDARY Incidence of Extracranial Bleeding |
3.6; 2.1 | — |
| SECONDARY Incidence of Intracranial Bleeding |
0.4; 0.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Non-valvular atrial fibrillation
Exclusion Criteria
- 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]
Data sourced from ClinicalTrials.gov (NCT05256797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.