UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004627 |
|---|---|
| Receipt number | R000005521 |
| Scientific Title | Extended Treatment with Statin on Atheroma Regression Evaluated by Intravascular Ultrasound with Virtual Histology (Extended TRUTH Study) |
| Date of disclosure of the study information | 2010/11/26 |
| Last modified on | 2012/08/21 11:24:37 |
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Basic information
Public title
Extended Treatment with Statin on Atheroma Regression Evaluated by Intravascular Ultrasound with Virtual Histology (Extended TRUTH Study)
Acronym
Extended TRUTH Study
Scientific Title
Extended Treatment with Statin on Atheroma Regression Evaluated by Intravascular Ultrasound with Virtual Histology (Extended TRUTH Study)
Scientific Title:Acronym
Extended TRUTH Study
Region
| Japan |
Condition
Condition
Patients with stable angina or unstable angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among the subjects registered for the TRUTH Study, there were some patients for whom baseline and follow-up measurements of coronary artery plaque (obtained using VH-IVUS) were available. The effects of long-term lipid-lowering therapy with pitavastatin or pravastatin on changes in plaque will be investigated in these patients. Moreover, correlation between change in plaque composition and cardiovascular events will be evaluated. In addition, we will evaluate the impacts of serum markers or different type of statins on cardiovascular events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in component of coronary artery plaque measured by VH-IVUS
Key secondary outcomes
1)Vessel volume, Lumen volume, Plaque volume
2)Cardiovascular composite events (cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral infarction, unstable angina, revascularization except target lesion revascularization)
3)change of serum lipid (TC, LDL-C, TG, HDL-C)
4)others marker (hs-CRP)
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-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
Among subjects registered for the TRUTH Study, patients (FAS subjects) available for baseline and follow-up measurement of coronary artery plaque using VH-IVUS gave consent to participate in this research
Key exclusion criteria
1)Patients meeting the contraindications or relative contraindications for pitavastatin and pravastatin
2)Patients with hepatic disorder or with AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limits of normal
3)Patients with renal dysfunction(serum creatinine 2.0mg/dL or higher)
4)Patients with a history of severe muscular disorder or with CK(CPK) greater than 2.5 times of the upper limit of normal
5)Patients with acute myocardial infarction occurred within 24 hours
6)Patients having failed to PCI
7)Patients with cerebrovascular accident occurred within 1 month
8)Patients with concurrent or a history of malignant tumor within 5 years prior to start of the investigationak drug
9)Patients receiving LDL apheresis
10)Patients with homozygous familial hypercholesterolemia
11)Patients requiring the following prohibited concomitant drugs
12)Drug abusers
13)Patients participating in other studies
14)Patients ineligible for the study determined by doctors
Target sample size
119
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Michishita |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsuta-cho, Sakae-ku, Yokohama, 247-8581, Japan
TEL
045-891-2171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanagawa PTCA Conference
Division name
Office
Zip code
Address
TEL
Homepage URL
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
| 2010 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2010 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | 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 | 11 | Month | 26 | 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=R000005521
