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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004627
Receipt No. 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

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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
Email

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
Email

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005521

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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