UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003171 |
|---|---|
| Receipt number | 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 14:10:40 |
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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
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
kunihisakohno@msn.com
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Okayama Univesity Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003845
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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