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Japan Statin Treatment Against Recurrent Stroke (J-STARS)

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ClinicalTrials.gov Identifier: NCT00221104
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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 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 1, 2004
Actual Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Incidence Rate of Stroke and TIA [ Time Frame: up to 5 years ]
    Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)


Secondary Outcome Measures :
  1. Incidence Rate of Atherothrombotic Infarction [ Time Frame: up to 5 years ]
    Incidence rate of patients with atherothrombotic infarction

  2. Incidence Rate of Lacunar Infarction [ Time Frame: up to 5 years ]
    Incidence rate of patients with lacunar infarction

  3. Incidence Rate of Cardioembolic Infarction [ Time Frame: up to 5 years ]
    Incidence rate of patients with cardioembolic infarction

  4. Incidence Rate of Intracranial Hemorrhage [ Time Frame: up to 5 years ]
    Incidence rate of patients with intracranial hemorrhage



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

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

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


Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Investigators
Principal Investigator: Masayasu Matsumoto, MD, PhD Hiroshima University Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Translational Research Center for Medical Innovation, 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
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018
Last Verified: June 2017

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
stroke
brain ischemia
cerebrovascular accident
statin
hydroxymethylglutaryl-CoA reductase inhibitors
cholesterol
hypercholesterolemia
hyperlipidemia
multicenter studies
prospective studies
endpoint determination
randomized controlled trials
recurrence
pravastatin

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