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不整脈(心房細動)があり、正常な心拍リズムに戻す治療(除細動)を受ける予定の患者を対象とした、血液凝固抑制剤アピキサバンの研究

基本情報

NCT ID
NCT02100228
ステータス
完了
試験のフェーズ
第4相
試験タイプ
介入
目標被験者数
1,500
治験依頼者名
Pfizer

概要

Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and used to prevent clots forming in people with "AF". Other established blood thinners work by stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An example of this type is Warfarin (Coumadin). The good effects of all blood thinners are preventing clots, and they may also have bad effects of increasing the chance of bleeding. People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular rhythm, known medically as "cardioversion". When this is done, people are currently most commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

対象疾患

Atrial Fibrillation

介入

Apixaban(DRUG)
Parenteral heparin and/or oral Vitamin K antagonist(DRUG)

実施施設 (4)

公立陶生病院

Seto, Aichi-ken, Japan

地方独立行政法人 大阪府立病院機構 大阪急性期・総合医療センター

Osaka, Japan

東邦大学医療センター大橋病院

Meguro-ku, Tokyo, Japan

日本医科大学付属病院

Tokyo, Japan