Unique ID issued by UMIN | UMIN000030851 |
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Receipt number | R000035226 |
Scientific Title | Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research) |
Date of disclosure of the study information | 2018/01/17 |
Last modified on | 2021/02/06 09:33:55 |
Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
Comparative study of various DOACs for atrial fibrillation after cardiac surgery
Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
Comparative study of various DOACs for atrial fibrillation after cardiac surgery
Japan |
Patients who underwent cardiac surgery
Cardiovascular surgery |
Others
NO
The purpose of this study is to elucidate the effectiveness and problems of various DOACs for atrial fibrillation after cardiac surgery.
Safety,Efficacy
Confirmatory
Bleeding event
Ischemic cerebrovascular event
Renal dysfunction, Hemoglobin, pericardial effusion (UCG).
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
3
Treatment
Medicine |
Apixaban group(2.5mgX2/day or 5mgX2/day)
Edoxaban group (30mgX1/day or 60mgX1/day)
Riveroxaban group(10mgX1/day or 15mgX1/day)
20 | years-old | <= |
90 | years-old | > |
Male and Female
atrial fibrillation after cardiac surgery
valve replacement surgery
Doctor's decision not to register to this regimen
100
1st name | AKira |
Middle name | |
Last name | Sezai |
Nihon University School of Medicine
Department of Cardiovascular Surgery
173-8610
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
03-3972-8111
asezai.med@gmail.com
1st name | Akira |
Middle name | |
Last name | Sezai |
Nihon University School of Medicine
Department of Cardiovascular Surgery
173-8610
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
03-3972-8111
asezai.med@gmail.com
Nihon University
self funding
Self funding
Nihon University School of Medicine
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
03-3972-8111
asezai.med@gmail.com
NO
日本大学医学部付属板橋病院
2018 | Year | 01 | Month | 17 | Day |
https://www.jstage.jst.go.jp/article/atcs/advpub/0/advpub_oa.20-00213/_pdf/-char/en
Unpublished
https://www.jstage.jst.go.jp/article/atcs/advpub/0/advpub_oa.20-00213/_pdf/-char/en
135
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.
2021 | Year | 01 | Month | 19 | Day |
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.
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.
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.
Completed
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 07 | Day |
2014 | Year | 05 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2018 | Year | 01 | Month | 17 | Day |
2021 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035226
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