非弁膜性心房細動（不整脈の一種）患者における出血リスクが高い場合の、アピキサバンとワルファリンの安全性および有効性の比較

基本情報

NCT ID

NCT05471505

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

120,722

治験依頼者名

Pfizer

概要

* 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

対象疾患

依頼者（Sponsor）

実施施設 (1)