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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003171
Receipt No. R000003845
Scientific Title Effect of Pitavastatin and EPA on coronary artery calcification detected by computed tomography.
Date of disclosure of the study information 2010/03/01
Last modified on 2017/08/18

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Basic information
Public title Effect of Pitavastatin and EPA on coronary artery calcification detected by computed tomography.
Acronym PEACH trial
Scientific Title Effect of Pitavastatin and EPA on coronary artery calcification detected by computed tomography.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Ito
Organization Okayama Univesity Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name Department of Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Kunihisa Kohno
Organization Okayama Univesity hospital
Division name Department of Cardiovascular Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 12 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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