Secondary prevention of HMG-CoA reductase inhibitor against stroke

UMIN ID: C000000207

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: 3000
• 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: cerebrovascular events
• Secondary Outcome: Events of ischemic stroke (subtype analysis according to the TOAST classification) or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of vascular events, death of all causes, admission to the hospital, activity of daily life, modified Rankin score, dementia and cognitive impairment, death of all causes.

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 Sciences
• Source(s) of Monetary Support: The Japanese Ministry of Health, Labour and Welfare