UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002507 |
|---|---|
| Receipt number | R000003051 |
| Scientific Title | Effects of aggressive lipid-lowering therapy on atherosclerosis and multi-lipoprotein profiling in patients with coronary artery disease |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2015/09/28 16:59:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of aggressive lipid-lowering therapy on atherosclerosis and multi-lipoprotein profiling in patients with coronary artery disease
Acronym
Statin therapy against multi-lipoprotein profiling and atherosclerosis -Secondary- (SAMURAI Study -Secondary-)
Scientific Title
Effects of aggressive lipid-lowering therapy on atherosclerosis and multi-lipoprotein profiling in patients with coronary artery disease
Scientific Title:Acronym
Statin therapy against multi-lipoprotein profiling and atherosclerosis -Secondary- (SAMURAI Study -Secondary-)
Region
| Japan |
Condition
Condition
Patients with coronary artery disease
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 (intima-media thickness, pulse wave velocity or cardio-ankle vascular index) in hypercholesterolemia patients with 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 lipoprotein profile by LipoSEARCH.
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), and malondialdehyde-modified LDL.
2. high-sensitive CRP, adiponectin.
3. LDDd, EF, E/A, and DcT.
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 a first 1-3 months. After safety evaluation, the dose will be increased to 4 mg/day in order to achieve the goal of LDL-C of 70mg/dL and less.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with coronary artery disease who meet 1 of the following 4 conditions.
1. Acute myocardial infarction occurred at least one week before.
2. Old myocardial infarction.
3. Unstable angina pectoris.
4. > or = 50% stenosis evaluated by coronary angiography (or severe stenosis evaluated by CT), or angina pectoris with ischemic ECG change (including coronary spasm).
2) Patients with hypercholesterolemia
(LDL-C of 100mg/dL or more).
3) Patients 20 years or older.
4) Patients giving written consent on their own volition for participation in this clinical trial.
Key exclusion criteria
1) Patients who have suffered from stroke for the past three months.
2) Patients who have suffered from acute myocardial infarction for the past week.
3) Patients planning CABG in the study periods.
4) Patients planning addition or change of cilostazol in the study periods
5) Patients planning CAS in the study periods
6) Patients with active malignant tumor.
7) Patients with severe renal dysfunction.
8) Patients with severe hepatic dysfunction.
9) Patients with collagen disease.
10) Patients judged as being inappropriate for this study by investigators.
Target sample size
100
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, SHOWA-KU, NAGOYA, AICHI 466-8550
TEL
052-744-2149
murohara@med.nagoya-u.ac.jp
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, SHOWA-KU, 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
We received an unrestricted research grant support from KOWA Pharmaceutical
Organization
Division
Category of Funding Organization
Other
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
安城更生病院
一宮市民病院
市立四日市病院
大垣市民病院
岡崎市民病院
海南病院
春日井市民病院
刈谷豊田総合病院
県西部浜松医療センター
公立陶生病院
中部ろうさい病院
土岐市立総合病院
トヨタ記念病院
中津川市民病院
名古屋第一赤十字病院
名古屋第二赤十字病院
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24458957
Number of participants that the trial has enrolled
Results
We demonstrated that treatment with pitavastatin attenuated atherosclerotic plaque. This effect was associated with the level of HDL cholesterol, and was stronger in the absence of diabetes and metabolic syndrome in our ischemic heart disease patients.
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
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 16 | Day |
Last modified on
| 2015 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003051
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
