At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with atrial fibrillation anytime in baseline period or on index date, with definitive AF diagnosis in baseline period, on index date, or post-index period
- ✓Prescribed apixaban or warfarin on or after the day of AF diagnosis; first observed prescription defines index date and treatment cohort
- ✓Age 18 years or older on index date
- ✓No prior oral anticoagulant use in the 180 days before index date
- ✕Diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation, or mechanical-valvular atrial fibrillation during baseline or post-index period
- ✕Prosthetic heart valve procedure during baseline period
- ✕Cardiac surgery procedure during baseline period
- ✕Venous thromboembolism diagnosis during baseline period
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Effectiveness of Apixaban Compared to Warfarin in NVAF Patients at Higher Risk of Bleeding.
In Brief
An observational study for Non-valvular Atrial Fibrillation. Completed, enrolled 120,722 participants across 1 site.
Detailed Summary
* The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database. * Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots. * An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients. * Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial. * Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s). * This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding