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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000212
Receipt No. 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

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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
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 and Health 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 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
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 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
URL(English) https://upload.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


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