Atrial Fibrillation, Heart Failure
Conditions
Brief summary
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Were age greater than or equal to 65 years as of the index date * Had greater than or equal to 1 diagnosis of AF prior to or on the index date * Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date * Had 1 or more pharmacy claim for oral blood thinners
Exclusion criteria
* Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date * Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period * Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day * Had medical claim indicating VTE in the 12 months prior to index date Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of stroke/systemic embolism (SE) | Approximately 195 weeks |
| Incidence of major bleeding | Approximately 195 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of miocardial infarction (MI) | Approximately 195 weeks |
| Incidence of all cause mortality | Approximately 195 weeks |
| Incidence of all cause hospitalization | Approximately 195 weeks |
| Incidence of major adverse cardiac event | Approximately 195 weeks |
Countries
United States
Outcome results
None listed