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Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure

Completed
Conditions
Atrial Fibrillation
Heart 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
GroupInterventionDescription
Elderly individuals with NVAF and HF who are taking OAC'sNon-Interventional-
Primary Outcome Measures
NameTimeMethod
Incidence of stroke/systemic embolism (SE)Approximately 195 weeks
Incidence of major bleedingApproximately 195 weeks
Secondary Outcome Measures
NameTimeMethod
Incidence of miocardial infarction (MI)Approximately 195 weeks
Incidence of all cause mortalityApproximately 195 weeks
Incidence of all cause hospitalizationApproximately 195 weeks
Incidence of major adverse cardiac eventApproximately 195 weeks

Trial Locations

Locations (1)

Local Institution

🇺🇸

Ann Arbor, Michigan, United States

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