Unique ID issued by UMIN | UMIN000027808 |
---|---|
Receipt number | R000031778 |
Scientific Title | Effect of Direct Oral Anticoagulant (DOAC) in Adult Congenital Heart Disease Patients |
Date of disclosure of the study information | 2017/06/19 |
Last modified on | 2020/08/13 14:48:56 |
Effect of Direct Oral Anticoagulant (DOAC) in Adult Congenital Heart Disease Patients
ACHD-DOAC
Effect of Direct Oral Anticoagulant (DOAC) in Adult Congenital Heart Disease Patients
ACHD-DOAC
Japan |
Adult congenital heart disease
Cardiology |
Others
NO
To evaluate the efficacy and safety of Direct Oral Anticoagulant (DOAC) therapy compared with warfarin in adult congenital heart disease patients
Safety,Efficacy
Thromboembolic events and major bleeding events during administration
The following events during administration:
1) Minor bleeding events
2) Intracardiac thrombus
3) Other adverse events accompanying anticoagulant drug therapy
4) Changing (dose or type) or stopping anticoagulant drug therapy
5) Discontinuation of follow-up
6) Death
7) Hospitalization
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Prior registration or planned registration in the database called the Japanese Network of Cardiovascular Departments for Adult Congenital Heart Disease (JNCVD-ACHD), which was established by the Japanese Society for Adult Congenital Heart Disease
2) Age over 20 years old at the time of registration between 1/1/2011 and 31/6/2019
3) Treatment with one of the following anticoagulant drugs: warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban
1) Age less than 20 years old
2) Incapable of obtaining participant consent
3) Judged to be medically ineligible by the attending physician
600
1st name | Masaki |
Middle name | |
Last name | Ieda |
University of Tsukuba
Department of Cardiology, Faculty of Medicine
3058575
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.
029-853-3143
mieda@md.tsukuba.ac.jp
1st name | Tomoko |
Middle name | |
Last name | Ishizu |
University of Tsukuba
Department of Cardiology, Faculty of Medicine
3058575
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.
029-853-3143
tomoco@md.tsukuba.ac.jp
University of Tsukuba
University of Tsukuba
Other
University of Tsukuba
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.
029-853-3143
tomoco@md.tsukuba.ac.jp
NO
2017 | Year | 06 | Month | 19 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 12 | Day |
2019 | Year | 05 | Month | 09 | Day |
2017 | Year | 06 | Month | 12 | Day |
2022 | Year | 03 | Month | 31 | Day |
Planned study period: from 12 June 2017 until 31 March 2022
2017 | Year | 06 | Month | 19 | Day |
2020 | Year | 08 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031778
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |