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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000311
Receipt No. R000000403
Scientific Title Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology; TRUTH Study (Kanagawa PTCA Conference Regression Study 5; KPCR5)
Date of disclosure of the study information 2006/01/25
Last modified on 2012/08/21

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Basic information
Public title Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology; TRUTH Study (Kanagawa PTCA Conference Regression Study 5; KPCR5)
Acronym Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology; TRUTH Study (Kanagawa PTCA Conference Regression Study 5; KPCR5)
Scientific Title Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology; TRUTH Study (Kanagawa PTCA Conference Regression Study 5; KPCR5)
Scientific Title:Acronym Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology; TRUTH Study (Kanagawa PTCA Conference Regression Study 5; KPCR5)
Region
Japan

Condition
Condition Patients with stable or unstable angina
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of lipid-lowering therapy with statin (pitavastatin or pravastatin) on tissue characteristics of coronary plaque, lipid levels, and inflammatory markers in patients with stable or unstable angina
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of tissue characteristics in coronary plaque evaluated by intravascular ultrasound (IVUS) with Virtual Histology
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pitavastain group
Interventions/Control_2 pravastatin group
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with stable or unstable angina received PCI whose LDL-cholesterollevel is above 140mg/dL
Key exclusion criteria 1)Patients currently medicated with statins or other lipid lowering therapy 2)Patients meeting the contraindications or relative contraindications for pitavastatin and pravastatin 3)Patients with hepatic disorder (AST or ALT greater than 2.5 times of the normal upper limits) 4)Patients with renal dysfunction (serum creatinine 2.0mg/dL or higher) 5)Patients with a history of severe muscular disorder or increased CK (CPK) greater than 2.5 times of the normal upper limit 6)Patients with acute myocardial infarction occurred within 24 hours 7)Patients failed to PCI 8)Patients with cerebrovascular accident occurred within 1 month 9)Patients with concurrent or a history of malignant disease within 5 years 10)Patients receiving LDL apheresis 11)Patients with homozygous familial hypercholesterolemia 12)Patients requiring the following prohibited concomitant drugs 13)Drug abusers 14)Patients participating in other studies 15)Patients ineligible for the study determined by physicians
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Michishita
Organization Yokohama Sakae Kyosai Hospital
Division name Department of Internal medicine, Division of Cardiology
Zip code
Address 132 Katsura-cho, Sakae-ku, Yokohama, 247-8581, JAPAN
TEL 045-891-2171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Nozue
Organization Yokohama Sakae Kyosai Hospital
Division name Department of Internal medicine, Division of Cardiology
Zip code
Address
TEL
Homepage URL
Email yk411015@fsinet.or.jp

Sponsor
Institute Kanagawa PTCA Conference
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information
2006 Year 01 Month 25 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
2005 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 01 Month 25 Day
Last modified on
2012 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000403

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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