UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006887 |
|---|---|
| Receipt number | R000008045 |
| Scientific Title | Comparison of lipid control therapy for hypercholesterolemic patients received aortic valve replacement |
| Date of disclosure of the study information | 2011/12/31 |
| Last modified on | 2017/12/18 14:31:59 |
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Basic information
Public title
Comparison of lipid control therapy for hypercholesterolemic patients received aortic valve replacement
Acronym
Lipid control therapy for aortic valve replacement
Scientific Title
Comparison of lipid control therapy for hypercholesterolemic patients received aortic valve replacement
Scientific Title:Acronym
Lipid control therapy for aortic valve replacement
Region
| Japan |
Condition
Condition
Hypercholestelomic patients with aortic valve replacement for aortic valve stemosis
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparison of statin for redustion of postoperative prosthetic valve dysfunction in patients with aortic valve stenosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prosthetic valve dysfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional Therapy Group: Target LDL-C levels are more than 100mg/dL and in compliance with JASGL2007.Any hypolipidemic drugs are available.
Interventions/Control_2
Aggressive Therapy Group: 5mg Rosuvastatin will be orally administered once daily.Target LDL-C levels are 70 mg/dL and LDL-C/HDL-C raitio levels are 1.5. If these levels are not achieved, rosuvastatin doses are gradually increased to 20mg/day, and rosuvastatin + another hypolidismic drug.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients with aortic stenosis who had aortic valve replacement with biological valves.
2. Patients who are able to submit written consent agreement by themselves
3. LDL-C>140mg/dL(LDL-C>100mg/dL for patients received lipied lowering therapy)
4. Patients without a history of coronary artery disease
Key exclusion criteria
1. Patient with a history of coronary artery disease
2. Patients with a history of sensitivity to statins
3. Patients with active hepatic disease(ALT or AST>100IU/L or total bilirubin>2.5mg/dL)
4. Patient on hemodialysis
5. Patients with fasting serum TG >= 1000 mg/dL.
6. Patients with CK > 500 IU/L.
7. Patients that are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial.
8. Patients with drug abuse or alcoholic
9. Patients who are ineligible in the opinion of the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Morimoto |
Organization
Awaji Hospital, Hyogo, Japan
Division name
Division of Cardiovascular Surgery
Zip code
Address
1-6-6 Shimokamo, Sumoto, Hyogo 656-0013, Japan
TEL
0799-24-5704
yoshimor@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Morimoto |
Organization
Awaji Hospital, Hyogo, Japan
Division name
Division of Cardiovascular Surgery
Zip code
Address
1-6-6 Shimokamo, Sumoto, Hyogo 656-0013, Japan
TEL
0799-24-5704
Homepage URL
yoshimor@gmail.com
Sponsor or person
Institute
Awaji Hospital, Hyogo, Japan
Institute
Department
Personal name
Funding Source
Organization
Awaji Hospital, Hyogo, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立淡路病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 14 | Day |
Last modified on
| 2017 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008045
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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