Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure
Completed
- Conditions
- Atrial FibrillationHeart Failure
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT03508271
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60000
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
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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/exclusion criteria could apply
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elderly individuals with NVAF and HF who are taking OAC's Non-Interventional -
- Primary Outcome Measures
Name Time Method Incidence of stroke/systemic embolism (SE) Approximately 195 weeks Incidence of major bleeding Approximately 195 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Local Institution
🇺🇸Ann Arbor, Michigan, United States