UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Intensive LDL-C Lowering with High-dose Atorvastatin on Inflammation and Postoperative Organ Damage in Patients Undergone Coronary Artery Bypass Surgery
Title of the study (Brief title)	Effect of high-dose Atrovastatin on inflammation
Region	Japan

Condition
Condition	coronary artery disease
Classification by specialty	Cardiology Endocrinology and Metabolism Cardiovascular surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of high-dose Atrovastatin on inflammation of epicardial adipose tissue.
Basic objectives2	Others
Basic objectives -Others	To investigate whether high-dose statin administration affect to the inflammation of epicardial adipose tissue
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expression of inflammatory cytokines and adipocytekines from each adipose tissues
Key secondary outcomes	Lipid profiles, inflammatory markers, adipocytekines and blood cell counts in peripheral blood

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	20mg/day of Atrovastatin
Interventions/Control_2	Starting-dose statin
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	patients undergoing elective primary isolated coronary artery bypass surgery
Key exclusion criteria	Hemodialysis Undergoing with intensive statin therapy Stroke or acute myocardial infarction Emrgerncy/Urgent surgery Sever liver dysfunction Pregnancy (including suspected) Allergy or history of allergy
Target sample size	90

Research contact person
Name of lead principal investigator	Taira Yamamoto
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular surgery
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL	0338133111
Email	tyamamo@juntendo.ac.jp

Public contact
Name of contact person	Taira Yamamoto
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular surgery
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo
TEL	0338133111
Homepage URL
Email	tyamamo@juntendo.ac.jp

Sponsor
Institute	Juntendo University Hospital
Institute
Department

Funding Source
Organization	Juntendo University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Juntendo Urayasu Hospital
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

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 14 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 12 Day
Last modified on	2017 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007059