UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of lipid control therapy for hypercholesterolemic patients received aortic valve replacement
Title of the study (Brief title)	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	Yoshihisa Morimoto
Organization	Awaji Hospital, Hyogo, Japan
Division name	Division of Cardiovascular Surgery
Address	1-6-6 Shimokamo, Sumoto, Hyogo 656-0013, Japan
TEL	0799-24-5704
Email	yoshimor@gmail.com

Public contact
Name of contact person	Yoshihisa Morimoto
Organization	Awaji Hospital, Hyogo, Japan
Division name	Division of Cardiovascular Surgery
Address	1-6-6 Shimokamo, Sumoto, Hyogo 656-0013, Japan
TEL	0799-24-5704
Homepage URL
Email	yoshimor@gmail.com

Sponsor
Institute	Awaji Hospital, Hyogo, Japan
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008045