UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002600 |
|---|---|
| Receipt number | 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 18:19:34 |
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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
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
kenji@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003167
