UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000212 |
|---|---|
| Receipt number | R000000282 |
| Scientific Title | Effects of 3-hydroxy-3-methyglutaryl-coenzyme A (HMG-CoA) reductase inhibitor upon carotid intima-media complex thickness in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS. |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2019/06/12 11:12:55 |
* 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 3-hydroxy-3-methyglutaryl-coenzyme A (HMG-CoA) reductase inhibitor upon carotid intima-media complex thickness in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS.
Acronym
Carotid intima-media thickness in Japan Statin Treatment Against Recurrent Stroke (J-STARS echo sub Study)
Scientific Title
Effects of 3-hydroxy-3-methyglutaryl-coenzyme A (HMG-CoA) reductase inhibitor upon carotid intima-media complex thickness in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS.
Scientific Title:Acronym
Carotid intima-media thickness in Japan Statin Treatment Against Recurrent Stroke (J-STARS echo sub Study)
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study establish an effect of HMG-CoA reductase inhibitor upon intima-media complex thickness (IMT) of the common carotid artery from the ischemic stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Intima-media complex thickness (IMT) of the common carotid artery (CCA)
Key secondary outcomes
Plaque score, number of plaque, recurrent cerebrovascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be randomized into the group receiving pravastatin or that having no statin. Intervention consists of pravastain treatment (10mg/day), that will start within 1 month of entry and continue until the full duration of study or the end-points.
Interventions/Control_2
Non-administration group of pravastatin (control 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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
2) 45-80 years old
3) Patients diagnosed as hyperlipidemia
4) No medication of statin within previous 30 days.
5) The total cholesterol level of 180-240mg/dl under no prescription of statin in the previous 30 days
6) Able to visit outpatient department
7) Informed consent on the form filled out by the patient.
Key exclusion criteria
1) Ischemic stroke of other determined causea according to the TOAST classification
2) Ischemic heart disease necessary to require statin
3) Hemorrhagic disorders
4) Platelet count less than 100,000/ul within 3 months before study starts
5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 100IU/L within 3 months prior to start of study
6) Serum creatinine more than 2.0mg/dl within 3 months prior to study.
7) Any scheduled operations.
8) The presence of malignant disorder
9) The patients participated in another clinical trial
10) The patient considered being unsuitable for the participation to the study by the medical doctor's judgment.
11) Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis
12) Patients after carotid endarterectomy or radiation therapy to neck
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Masayasu |
| Middle name | |
| Last name | Matsumoto |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
734-8551
Address
1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5200
naika3@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Hosomi |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Clinical Neuroscience and Therapeutics
Zip code
734-8551
Address
1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5201
Homepage URL
http://jstars.umin.ne.jp
naika3@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cardiovascular Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital Center for Integrated Medical Reserch
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1752
protocol@cimr.hiroshima-u.ac.jp
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
| 2005 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2003 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2004 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000282
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
