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Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation

CompletedN/A

Sponsor: Pfizer

Conditions: Non-valvular Atrial Fibrillation

Interventions: Apixaban, Warfarin

Countries: Japan

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 Japanese secondary prevention patients as Real World Evidence (RWE) on the effectiveness and safety of apixaban compared to warfarin in patients with non-valvular atrial fibrillation (NVAF).

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

Patients must meet all the following selection criteria

1. Patients registered in the Medical Data Vision (MDV) database 2008 though 2021.
2. Patients newly with non-valvular atrial fibrillation
3. Patients who newly receive warfarin or apixaban after diagnosis of NVAF
4. Age 20 years or older on the index date
5. 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 Criteria:

Patients who meet the following exclusion criteria will be excluded from this study

1. 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.
2. Patients with a diagnosis of venous thromboembolism (VTE) during the baseline period
3. Patients who are prescribed any anticoagulants before index date.
4. Patients who are prescribed anticoagulants other than warfarin and apixaban on the index date
5. Patients who are continuously hospitalized due to the first incidence of stroke or other serious diseases.

Locations (1)

Tokyo, Japan