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

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

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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

MedlinePlus related topics: Cholesterol Medicines Ischemic Stroke Statins

Drug Information available for: Pravastatin Pravastatin sodium

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 :

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 :

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

Eligibility Criteria

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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

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

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

Locations

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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

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Principal Investigator:	Masayasu Matsumoto, MD, PhD	Hiroshima University Hospital

More Information

Additional Information:

Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in Japanese This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.

Hosomi N, Nagai Y, Kitagawa K, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS collaborators. Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event. J Atheroscler Thromb. 2018 Mar 1;25(3):262-268. doi: 10.5551/jat.40196. Epub 2017 Sep 16.

Nakamura M, Fukukawa T, Kitagawa K, Nagai Y, Hosomi N, Minematsu K, Uchiyama S, Matsumoto M, Miyamoto Y; for J-STARS collaborators. Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke. Ann Clin Biochem. 2018 Jan;55(1):128-135. doi: 10.1177/0004563217693651. Epub 2017 Jul 10.

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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

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:

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Stroke Ischemic 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

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