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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000207
Receipt No. R000000277
Scientific Title Secondary prevention of HMG-CoA reductase inhibitor against stroke
Date of disclosure of the study information 2005/09/13
Last modified on 2019/06/12

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Basic information
Public title Secondary prevention of HMG-CoA reductase inhibitor against stroke
Acronym Japan Statin Treatment Against Reccurent Stroke (J-STARS)
Scientific Title Secondary prevention of HMG-CoA reductase inhibitor against stroke
Scientific Title:Acronym Japan Statin Treatment Against Reccurent Stroke (J-STARS)
Region
Japan

Condition
Condition Ischemic stroke
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although it is unclear if hyperlipidemia is a risk factor of stroke or not, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase can decrease the incidence of stroke in the patients with ischemic heart disease. The neuroprotective mechanism beyond cholesterol-lowering effects could be expected to attenuate cerebrovascular inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents the ischemic stroke patients from recurrent stroke safe and sound.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes cerebrovascular events
Key secondary outcomes Events of ischemic stroke (subtype analysis according to the TOAST classification) or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of vascular events, death of all causes, admission to the hospital, activity of daily life, modified Rankin score, dementia and cognitive impairment, death of all causes.

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 end of study or the endpoints.
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 taking of HMG-CoA reductase inhibitor, any statin, within previous 30 days.
5) The total cholesterol level of 180-240mg/dl without the prescription of statin within 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
Target sample size 3000

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
TEL 082-257-5200
Email 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
Email naika3@hiroshima-u.ac.jp

Sponsor
Institute Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical Sciences
Institute
Department

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
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
Email 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 Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S2352396415301006
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
2003 Year 12 Month 17 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 07 Month 01 Day
Date analysis concluded
2014 Year 09 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000277

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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