UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000311 |
|---|---|
| Receipt number | 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 11:23:52 |
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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
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
yk411015@fsinet.or.jp
Sponsor or person
Institute
Kanagawa PTCA Conference
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000403
