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Japan Statin Treatment Against Recurrent Stroke (J-STARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00221104
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 25, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Pravastatin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
Study Start Date : March 2004
Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Statins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Pravastatin
Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.
Drug: Pravastatin
No Intervention: No intervention
Patient has no intervention.

Outcome Measures

Primary Outcome Measures :
  1. cerebrovascular events [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

Secondary Outcome Measures :
  1. subtype of ischemic stroke according to the TOAST classification or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of cerebrovascular and cardiovascular [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

Eligibility Criteria

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
  • Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
  • Able to visit outpatient department
  • Informed consent on the form.

Exclusion Criteria:

  • Ischemic stroke of other determined cause according to the TOAST classification
  • Ischemic heart disease and necessary to use statin
  • Hemorrhagic disorders
  • Platelet count <=100,000/ul within 3 months prior to study start
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
  • Serum creatinine >=2.0mg/dl within 3 months prior to study start
  • A scheduled operation
  • The presence of malignant disorder
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221104

Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Principal Investigator: Masayasu Matsumoto, MD, PhD Hiroshima University Hospital
More Information

Additional Information:
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00221104     History of Changes
Other Study ID Numbers: J-STARS
C000000207 ( Other Identifier: UMIN CTR )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: March 2015

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
brain ischemia
cerebrovascular accident
hydroxymethylglutaryl-CoA reductase inhibitors
multicenter studies
prospective studies
endpoint determination
randomized controlled trials

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors