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経口FXIa阻害剤BAY 2433334の適切な投与量に関する情報を収集し、心臓関連の合併症を引き起こす可能性のある不整脈(心房細動)患者における、非ビタミンK経口抗凝固薬(NOAC)であるアピキサバンとの安全性を比較する研究。

基本情報

NCT ID
NCT04218266
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
755
治験依頼者名
Bayer

概要

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor. Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.

対象疾患

Atrial Fibrillation (AF)

介入

BAY2433334(DRUG)
Apixaban(DRUG)
BAY2433334 matching placebo(OTHER)
Apixaban matching placebo(OTHER)

依頼者(Sponsor)

実施施設 (9)

兵庫県立はりま姫路総合医療センター

Himeji, Hyōgo, Japan

医療法人徳洲会岸和田徳洲会病院

Kishiwada, Osaka, Japan

Hayama Heart Center

Miura-gun, Kanagawa, Japan

Nishiarai Heart Central Clinic

Adachi-ku, Tokyo, Japan

医療法人順心会 中村循環器科・心臓外科医院

Itoshima, Fukuoka, Japan

医療法人徳洲会 八尾徳洲会総合病院

Yao, Osaka, Japan

Tokyo Angel Hospital

Hachiōji, Tokyo, Japan

医療法人社団健心会 みなみ野循環器病院

Hachiōji, Tokyo, Japan

社会医療法人社団順江会 江東病院

Koto-ku, Tokyo, Japan