Status:
COMPLETED
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
Lead Sponsor:
Pfizer
Conditions:
Non-valvular Atrial Fibrillation
Eligibility:
All Genders
80+ years
Brief Summary
The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF). In addition to the absolu...
Detailed Description
This is a retrospective non-intervention observational study to evaluate the difference in safety and effectiveness between apixaban and warfarin using a database provided by Medical Data Vision Co. L...
Eligibility Criteria
Inclusion
- Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.
- Diagnosed with Atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
- Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
- No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)
- Age of 18 years or older on the index date.
- Index date is at age 80 or older
Exclusion
- Patients meeting any of the following criteria will not be included in the study:
- Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
- Having a cardiac surgery procedure record during the baseline period
- Having a joint replacement procedure record during the baseline period
- Having a procedure of prosthetic heart valve during the baseline period
- Having a diagnosis of venous thromboembolism during the baseline period
- Female patients with pregnancy during the follow-up period
- Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
77814 Patients enrolled
Trial Details
Trial ID
NCT05438888
Start Date
July 1 2022
End Date
October 19 2022
Last Update
May 20 2024
Active Locations (1)
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1
Pfizer Site
Tokyo, Japan