UMIN ID: C000000212
Registered date:13/09/2005
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.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Ischemic stroke |
Date of first enrollment | 2004/03/01 |
Target sample size | 800 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 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. Non-administration group of pravastatin (control group) |
Outcome(s)
Primary Outcome | Intima-media complex thickness (IMT) of the common carotid artery (CCA) |
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Secondary Outcome | Plaque score, number of plaque, recurrent cerebrovascular events |
Key inclusion & exclusion criteria
Age minimum | 45years-old |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences |
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Secondary Sponsor | National Cardiovascular Center |
Source(s) of Monetary Support | The Japanese Ministry of Health, Labour and Welfare |
Secondary ID(s) |
Contact
public contact | |
Name | Naohisa Hosomi |
Address | 1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan Japan 734-8551 |
Telephone | 082-257-5201 |
naika3@hiroshima-u.ac.jp | |
Affiliation | Hiroshima University Graduate School of Biomedical and Health Sciences Department of Clinical Neuroscience and Therapeutics |
scientific contact | |
Name | Masayasu Matsumoto |
Address | 1-2-3 kasumi, Minami-ku, Hiroshima 734-8551, Japan Japan |
Telephone | 082-257-5200 |
naika3@hiroshima-u.ac.jp | |
Affiliation | Hiroshima University Graduate School of Biomedical and Health Sciences Department of Clinical Neuroscience and Therapeutics |