Unique ID issued by UMIN | UMIN000008178 |
---|---|
Receipt number | R000004435 |
Scientific Title | Effect on durability of bovine pericardial valve after replacement of heart valve |
Date of disclosure of the study information | 2012/06/15 |
Last modified on | 2020/09/08 17:54:22 |
Effect on durability of bovine pericardial valve after replacement of heart valve
ENDURANCE
Effect on durability of bovine pericardial valve after replacement of heart valve
ENDURANCE
Japan |
Status post aortic valve replacement with bioprosthetic valve
Cardiovascular surgery |
Others
NO
Statin therapy would halt the progression of calcification of bioprosthetic valve. We evaluate the favorable effect of statins to the calcification of the bioprosthetic valve and its durability.
Efficacy
Confirmatory
Pragmatic
Phase III
Primary outcomes: Velocity and pressure gradient of bioprosthetic aortic valve
(6, 12, 24, 36 months after AVR)
Secondary outcomes: Calcification score (Agatston score) of bioprosthetic aortic valve
(24months after AVR)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
NO
NO
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Interventions:Livalo(pitavastatin)
Period:3-5years
medication:livalo 2~4mg/day
control:no medication
Period:3-5years
20 | years-old | <= |
Not applicable |
Male and Female
Patients who underwent AVR operation using bioprosthetic valve.
hyperlipidemia
coronary artery disease
malignancy
60
1st name | |
Middle name | |
Last name | Kumagai Kiichiro |
Tohoku University
Department of Cardiovascular Surgery
1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
022-717-7222
1st name | |
Middle name | |
Last name | Kumagai Kiichiro |
Tohoku University
Research Division of Sciences for Aortic Disease
1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
022-717-7222
kkumagai@med.tohoku.ac.jp
Department of Cardiovascular Surgery, Tohoku University
Tohoku University
Self funding
Japan
Tohoku Kosei Nenkin hospital
Sendai Open hospital
Miyagi Cardiovascular and respiratory center
NO
東北大学病院(宮城県)
2012 | Year | 06 | Month | 15 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2012 | Year | 06 | Month | 15 | Day |
2020 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004435
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |