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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002600
Receipt No. R000003167
Scientific Title Effects of HMG-CoA reductase inhibitor on atherosclerosis and multi-lipoprotein profiling in patients without coronary artery disease
Date of disclosure of the study information 2009/10/15
Last modified on 2012/10/04

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Basic information
Public title Effects of HMG-CoA reductase inhibitor on atherosclerosis and multi-lipoprotein profiling in patients without coronary artery disease
Acronym Statin therapy against multi-lipoprotein profiling and atherosclerosis -Primary- (SAMURAI Study - Primary -)
Scientific Title Effects of HMG-CoA reductase inhibitor on atherosclerosis and multi-lipoprotein profiling in patients without coronary artery disease
Scientific Title:Acronym Statin therapy against multi-lipoprotein profiling and atherosclerosis -Primary- (SAMURAI Study - Primary -)
Region
Japan

Condition
Condition Patients with hypercholesterolemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficiency of pitavastatin against small LDL particle, oxidative LDL (malondialdehyde-modified LDL), and the markers of atherosclerosis (endothelial function (PAT), intima-media thickness, pulse wave velocity or cardio-ankle vascular index) in hypercholesterolemia patients without coronary artery disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in endothelial function (PAT), Change in brachial-ankle pulse wave velocity or cardio-ankle vascular index, Change in intima-media thickness (max IMT, mean IMT)
Key secondary outcomes A percent and amount of changes in following factors
1. Serum lipid profile (TC,LDL-C, HDL-C, TG), apolipoprotein (A1, B), beta-lipoprotein, lipoprotein profile by LipoSEARCH, malondialdehyde-modified LDL, CETP
2. high-sensitive CRP, adiponectin, reactive oxygen metabolites (d-ROMs), fasting inslin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin 2 mg daily for 12 months.
Interventions/Control_2
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with hypercholesterolemia
(LDL-C of 140mg/dL or more)
Key exclusion criteria 1) Patients who have taken statins.
2) Patients who have suffered from acute myocardial infarction for the past 3 months.
3) Patients undergoing CABG or PCI for the past 3 months, or planning CABG or PCIin the study periods.
4) Patients with active malignant tumor.
5) Patients with severe renal dysfunction.
6) Patients with severe hepatic dysfunction.
7) Patients with collagen disease.
8) Patients during pregnancy and nursing.
9) Patients who do not accept informed consent.
10) Patients judged as being inappropriate for this study by investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoaki Murohara
Organization Nagoya University Graduate School of Medicine
Division name Department of Cardiology
Zip code
Address 65, TURUMAI-CHO, SHOWAKU, NAGOYA, AICHI 466-8550
TEL 052-744-2149
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Okumura
Organization Nagoya University, Graduate School of Medicine
Division name Department of Cardiology
Zip code
Address 65, TURUMAI-CHO, SHOWAKU, NAGOYA, AICHI 466-8550
TEL 052-744-2427
Homepage URL
Email kenji@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 10 Month 15 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
2009 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 08 Day
Last modified on
2012 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003167

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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