UMIN-CTR Clinical Trial

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