NCT05438888

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

Safety and Effectiveness of Apixaban in Very Elderly Patients With NVAF Compared to Warfarin Using Administrative Claims Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77,814 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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

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. Ltd. (MDV Co. Ltd.). Eligible patients will be extracted from the database and allocated to the pre-defined cohorts based on the actual age, age of NVAF diagnosis and types of anticoagulant therapy. Patient characteristics will be balanced by an Inverse probability of treatment weighting (IPTW) method, and risk of stroke/SE (primary effectiveness endpoint) and major bleeding (primary safety endpoint) will be compared.

Conditions

• Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Warfarin	This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings.
DRUG	Apixaban	This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings.

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2022-06-30
• Last updated: 2024-05-20
• Results posted: 2024-05-20

Locations

1 site across 1 country: Japan