Unique ID issued by UMIN | C000000211 |
---|---|
Receipt number | R000000281 |
Scientific Title | Effects of 3-hydroxy-3-methyglutaryl-coenzyme A(HMG-CoA)reductase inhibitor upon the serum high sensitive CRP 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 11:05:45 |
Effects of 3-hydroxy-3-methyglutaryl-coenzyme A(HMG-CoA)reductase inhibitor upon the serum high sensitive CRP in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS.
hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
Effects of 3-hydroxy-3-methyglutaryl-coenzyme A(HMG-CoA)reductase inhibitor upon the serum high sensitive CRP in the post-ischemic patients with hyperlipidemia during the prospective study of J-STARS.
hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
Japan |
Ischemic stroke
Neurology | Neurosurgery |
Others
NO
This study examines an effect of HMG-CoA reductase inhibitor on serum hsCRP concentration from the ischemic stroke patients
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Serum high sensitive CRP concentration
Recurrent stroke
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
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.
Non-administration group of pravastatin (control group)
45 | years-old | <= |
80 | years-old | >= |
Male and Female
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 prescription of statin within previous 30 days
5) The total cholesterol level of 180-240mg/dl within previous 30 days
6) Allowed to visit outpatient department
7) Informed consent on the form filled out by the patient.
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.
1200
1st name | Masayasu |
Middle name | |
Last name | Matsumoto |
Hiroshima University Graduate School of Biomedical and Health Sciences
Department of Clinical Neuroscience and Therapeutics
734-8551
1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan
082-257-5200
naika3@hiroshima-u.ac.jp
1st name | Naohisa |
Middle name | |
Last name | Hosomi |
Hiroshima University Graduate School of Biomedical and Health Sciences
Department of Clinical Neuroscience and Therapeutics
734-8551
1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan
082-257-5201
http://jstars.umin.ne.jp
naika3@hiroshima-u.ac.jp
Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences
The Japanese Ministry of Health, Labour and Welfare
Other
Japan
Osaka University
Hiroshima University Hospital Center for Integrated Medical Research
1-2-3 Kasumi, Minami-ku, HIroshima
082-257-1752
protocol@cimr.hiroshima-u.ac.jp
NO
2005 | Year | 09 | Month | 13 | Day |
Partially published
Completed
2003 | Year | 12 | Month | 23 | Day |
2004 | Year | 02 | Month | 06 | Day |
2004 | Year | 03 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2005 | Year | 09 | Month | 13 | Day |
2019 | Year | 06 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000281
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |