Status:
COMPLETED
Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation
Lead Sponsor:
Pfizer
Conditions:
Non-valvular Atrial Fibrillation
Eligibility:
All Genders
20+ years
Brief Summary
The purpose of this study are 1) to characterize the primary and secondary prevention patients, 2) to calculate incidence rates of stroke/SE or major bleeding in each cohort and 3) to investigate for ...
Detailed Description
Japanese population has shown to have higher rate of incidence of stroke and stroke mortality is also higher. Patients with a history of ischemic stroke are at high risk of recurrence and require more...
Eligibility Criteria
Inclusion
- Patients must meet all the following selection criteria
- Patients registered in the Medical Data Vision (MDV) database 2008 though 2021.
- Patients newly with non-valvular atrial fibrillation
- Patients who newly receive warfarin or apixaban after diagnosis of NVAF
- Age 20 years or older on the index date
- Patients who have a history of stroke or transient ischemic attack (TIA) are inclusion criteria only for secondary prevention cohort, otherwise patients will be concluded in the primary prevention cohort.
Exclusion
- Patients who meet the following exclusion criteria will be excluded from this study
- Patients with a diagnosis of valvular AF (standard disease code: 8846941), postoperative AF (8847772), AF associated with mechanical valve malfunction (T82.0), mechanical complication of heart valve prosthesis (T82.0), or rheumatic AF (I05-I09) during the baseline period.
- Patients with a diagnosis of venous thromboembolism (VTE) during the baseline period
- Patients who are prescribed any anticoagulants before index date.
- Patients who are prescribed anticoagulants other than warfarin and apixaban on the index date
- Patients who are continuously hospitalized due to the first incidence of stroke or other serious diseases.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
193565 Patients enrolled
Trial Details
Trial ID
NCT05321810
Start Date
April 15 2022
End Date
April 15 2022
Last Update
January 11 2024
Active Locations (1)
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1
Pfizer
Tokyo, Japan