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
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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 |

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.
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Drug: Pravastatin |
No Intervention: No intervention
Patient has no intervention.
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- 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)
- Incidence Rate of Atherothrombotic Infarction [ Time Frame: up to 5 years ]Incidence rate of patients with atherothrombotic infarction
- Incidence Rate of Lacunar Infarction [ Time Frame: up to 5 years ]Incidence rate of patients with lacunar infarction
- Incidence Rate of Cardioembolic Infarction [ Time Frame: up to 5 years ]Incidence rate of patients with cardioembolic infarction
- 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, Older Adult) |
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

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
Japan | |
Hiroshima University | |
Hiroshima, Japan, 734-8551 |
Principal Investigator: | Masayasu Matsumoto, MD, PhD | Hiroshima University Hospital |
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 |
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 |
stroke brain ischemia cerebrovascular accident statin hydroxymethylglutaryl-CoA reductase inhibitors cholesterol hypercholesterolemia |
hyperlipidemia multicenter studies prospective studies endpoint determination randomized controlled trials recurrence pravastatin |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pravastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |