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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000030851
受付番号 R000035226
科学的試験名 心臓手術後心房細動に対する各種DOACの比較研究(前向き観察研究)
一般公開日(本登録希望日) 2018/01/17
最終更新日 2021/02/06

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 心臓手術後心房細動に対する各種DOACの比較研究(前向き観察研究) Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
一般向け試験名略称/Acronym 心臓手術後心房細動に対する各種DOACの比較研究 Comparative study of various DOACs for atrial fibrillation after cardiac surgery
科学的試験名/Scientific Title 心臓手術後心房細動に対する各種DOACの比較研究(前向き観察研究) Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
科学的試験名略称/Scientific Title:Acronym 心臓手術後心房細動に対する各種DOACの比較研究 Comparative study of various DOACs for atrial fibrillation after cardiac surgery
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 心臓手術患者 Patients who underwent cardiac surgery
疾患区分1/Classification by specialty
心臓血管外科学/Cardiovascular surgery
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 心臓手術後心房細動に対する各種DOACの有効性と問題点を解明する The purpose of this study is to elucidate the effectiveness and problems of various DOACs for atrial fibrillation after cardiac surgery.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes 出血イベント
虚血性脳血管イベント
Bleeding event
Ischemic cerebrovascular event
副次アウトカム評価項目/Key secondary outcomes 腎障害、ヘモグロビン値、心のう液(心臓超音波検査)など Renal dysfunction, Hemoglobin, pericardial effusion (UCG).

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 3
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1 アピキサバン群(2.5mgX2/day or 5mgX2/day) Apixaban group(2.5mgX2/day or 5mgX2/day)
介入2/Interventions/Control_2 エドキサバン群 (30mgX1/day or 60mgX1/day) Edoxaban group (30mgX1/day or 60mgX1/day)
介入3/Interventions/Control_3 リバーロキサバン群 (10mgX1/day or 15mgX1/day) Riveroxaban group(10mgX1/day or 15mgX1/day)
介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
90 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 心臓手術後心房細動発生例(人工弁置換を除く) atrial fibrillation after cardiac surgery
除外基準/Key exclusion criteria 人工弁置換症例
主治医が不適と判断した症例
valve replacement surgery
Doctor's decision not to register to this regimen
目標参加者数/Target sample size 100

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
ミドルネーム
瀬在
AKira
ミドルネーム
Sezai
所属組織/Organization 日本大学医学部 Nihon University School of Medicine
所属部署/Division name 心臓血管外科 Department of Cardiovascular Surgery
郵便番号/Zip code 173-8610
住所/Address 東京都板橋区大谷口上町30-1 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
電話/TEL 03-3972-8111
Email/Email asezai.med@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
ミドルネーム
瀬在
Akira
ミドルネーム
Sezai
組織名/Organization 日本大学医学部 Nihon University School of Medicine
部署名/Division name 心臓血管外科 Department of Cardiovascular Surgery
郵便番号/Zip code 173-8610
住所/Address 東京都板橋区大谷口上町30-1 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
電話/TEL 03-3972-8111
試験のホームページURL/Homepage URL
Email/Email asezai.med@gmail.com

実施責任組織/Sponsor
機関名/Institute 日本大学 Nihon University
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization 自己調達 self funding
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 日本大学医学部 Nihon University School of Medicine
住所/Address 東京都板橋区大谷口上町30-1 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
電話/Tel 03-3972-8111
Email/Email asezai.med@gmail.com

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions 日本大学医学部付属板橋病院

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 01 17

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.jstage.jst.go.jp/article/atcs/advpub/0/advpub_oa.20-00213/_pdf/-char/en
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications https://www.jstage.jst.go.jp/article/atcs/advpub/0/advpub_oa.20-00213/_pdf/-char/en
組み入れ参加者数/Number of participants that the trial has enrolled 135
主な結果/Results Results: Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivarox- aban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were signi cantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups.
Results: Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivarox- aban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were signi cantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups.
主な結果入力日/Results date posted
2021 01 19
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC. In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC.
参加者の流れ/Participant flow In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC. In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC.
有害事象/Adverse events Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivarox- aban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were signi cantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups. Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivarox- aban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were signi cantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups.
評価項目/Outcome measures We de ned the primary endpoints: major bleeding events that required a blood transfusion such as major postoperative bleeding, GI bleeding, or cerebral hemor- rhage; minor bleeding events that were clinically signi - cant; thromboembolic events; and the last day of the 2-month treatment period. The secondary endpoints were as follows: hemoglobin (Hb), sCr and CRCL were at baseline levels on days 1 and 3, week 1, and month 1; prothrombin time (PT) was at baseline levels on day 1, week 1, and month 1; and activated partial thromboplas- tin time (APTT) was at baseline levels on day 1, week 1, and month 1. We de ned the primary endpoints: major bleeding events that required a blood transfusion such as major postoperative bleeding, GI bleeding, or cerebral hemor- rhage; minor bleeding events that were clinically signi - cant; thromboembolic events; and the last day of the 2-month treatment period. The secondary endpoints were as follows: hemoglobin (Hb), sCr and CRCL were at baseline levels on days 1 and 3, week 1, and month 1; prothrombin time (PT) was at baseline levels on day 1, week 1, and month 1; and activated partial thromboplas- tin time (APTT) was at baseline levels on day 1, week 1, and month 1.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2014 04 01
倫理委員会による承認日/Date of IRB
2014 04 07
登録・組入れ開始(予定)日/Anticipated trial start date
2014 05 01
フォロー終了(予定)日/Last follow-up date
2019 12 31
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 01 17
最終更新日/Last modified on
2021 02 06


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035226
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035226

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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