UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Pitavastatin and EPA on coronary artery calcification detected by computed tomography.
Title of the study (Brief title)	PEACH trial
Region	Japan

Condition
Condition	Patient with dyslipidemia and with coronary artery calcification.(Agatston score 1-999) (Patient of primary prevention of coronary heart disease)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Pitavastatin on coronary calcification score. (compariosn with highdose treatment and combination with EPA)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The effect of Pitavastatin on coronary calcification score. (compariosn with highdose treatment and combination with EPA)
Key secondary outcomes	1) The ratio of achivement of LDL-C level on Guidline. 2) Changes in TC, LDL-C, TG, HDL-C, adiponectin, fatty asid furaction, RLP-C, subfraction of HDL, hs-CRP, MCP-1, Oxdative LDL, Quantification of CD34, RBC, WBC, Hb, Ht, platelate, BNP, creatinin, BUN, uricacid, total bilirubin, AST, ALT, gamma-GTP, CK(CPK), LDH, serum Na, serum K, serum Cl, FBS, fasting insulin 3)The ratio of MACCE 4)The ratio of adverse effect 5)The relation between clinical parameter and coronary calcification score, relation between clinical parameter and ratio of MACCE.

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pitavastatin 2mg
Interventions/Control_2	Pitavastatin 4mg
Interventions/Control_3	Pitavastatin 2mg and EPA 1800mg
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Dyslipidemia patient defined by guidline, or already treated by anti-dyslipidemia drugs. 2)Patient without recived PCI and CABG 3)Patient coronary CT within two months., And detected coronary artery calcification(Agatston score 1-999). 4)Over 20 years old.
Key exclusion criteria	1)Patient with PCI or CABG. 2)Patient can't obtained clear CT image. 3Patient without coronary artery calcification(Agatsuton score=0) 4)Patient with heaviry-calcification on coronary artery (Agatston score >=1000) 5)Patient who are favorite to treat with anti-dyslipidemia drugs other than statin. 6)Famirial hypercholesterolemia. 7)Patient corresponded contraindication of Pitavastatin. 8)Patient considered to be improper to this trial by attending doctor.
Target sample size	240

Research contact person
Name of lead principal investigator	Hiroshi Ito
Organization	Okayama Univesity Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name	Department of Cardiovascular Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Email	itomd@md.okayama-u.ac.jp

Public contact
Name of contact person	Kunihisa Kohno
Organization	Okayama Univesity hospital
Division name	Department of Cardiovascular Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Homepage URL
Email	kunihisakohno@msn.com

Sponsor
Institute	Department of Cardiovascular Medicine, Okayama Univesity Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Japan Heart Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	赤穂中央病院（兵庫県）、岩国医療センター（山口県）、愛媛県立中央病院（愛媛県）、岡山医療センター（岡山県）、岡山済生会総合病院（岡山県）、岡山市民病院（岡山県）、岡山赤十字病院（岡山県）、岡山大学病院（岡山県）、岡山労災病院（岡山県）、尾道市民病院（広島県）、香川県立中央病院（香川県）、笠岡第一病院（香川県）、済生会今治病院（岡山県）、済生会松山病院（愛媛県）、住友別子病院（愛媛県）、高松赤十字病院（香川県）、中国中央病院（広島県）、津山中央病院（岡山県）、鳥取市立病院（鳥取県）、久松内科循環器科（岡山県）、姫路赤十字病院（兵庫県）、福山医療センター（広島県）、福山市民病院（広島県）、福山循環器病院（広島県）、松山市民病院（愛媛県）、三豊総合病院（香川県）、屋島総合病院（香川県）

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 15 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2012 Year 09 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 12 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003845