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Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data

NCT05438888

CompletedN/A

Sponsor: Pfizer

Conditions: Non-valvular Atrial Fibrillation

Interventions: Warfarin, Apixaban

Countries: Japan

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 absolute age, effects on higher age-related risk factors on relative risk of apixaban to warfarin is also investigated through subgroup analyses.

Eligibility overview

Sex: ALL

Age: 80 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.

1. 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.
2. 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
3. No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)
4. Age of 18 years or older on the index date.
5. Index date is at age 80 or older

Exclusion Criteria:

* Patients meeting any of the following criteria will not be included in the study:

1. 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
2. Having a cardiac surgery procedure record during the baseline period
3. Having a joint replacement procedure record during the baseline period
4. Having a procedure of prosthetic heart valve during the baseline period
5. Having a diagnosis of venous thromboembolism during the baseline period
6. Female patients with pregnancy during the follow-up period
7. 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.

Locations (1)

Tokyo, Japan