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.

UMIN ID: C000000211

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ischemic stroke
• Date of first enrollment: 2004/03/01
• Target sample size: 1200
• 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 end of study or the endpoints.
Non-administration group of pravastatin (control group)

Outcome(s)

• Primary Outcome: Serum high sensitive CRP concentration
• Secondary Outcome: Recurrent stroke

Key inclusion & exclusion criteria

• Age minimum: 45years-old
• Age maximum: 80years-old
• Gender: Male and Female
• 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.

Related Information

• Primary Sponsor: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences
• Secondary Sponsor: Osaka University
• Source(s) of Monetary Support: The Japanese Ministry of Health, Labour and Welfare