Japan Statin Treatment Against Recurrent Stroke (J-STARS)

This study is currently recruiting participants.

Verified by Translational Research Informatics Center, Kobe, Hyogo, Japan, February 2009

First Received: September 13, 2005 Last Updated: February 9, 2009 History of Changes

Sponsors and Collaborators:	Translational Research Informatics Center, Kobe, Hyogo, Japan Ministry of Health, Labour and Welfare Hiroshima University
Information provided by:	Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT00221104

Purpose

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	Intervention	Phase
Ischemic Stroke	Drug: Pravastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:

cerebrovascular events

Secondary Outcome Measures:

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

Estimated Enrollment:	3000
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2014

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221104

Locations

Japan
Hiroshima University	Recruiting
Hiroshima, Japan, 734-8551
Contact: Masayasu Matsumoto, MD, PhD +81-82-257-5201 mack@hiroshima-u.ac.jp
Principal Investigator: Masayasu Matsumoto, MD, PhD

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

Ministry of Health, Labour and Welfare

Hiroshima University

Investigators

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

No publications provided

Study ID Numbers:	J-STARS
Study First Received:	September 13, 2005
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00221104 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Translational Research Informatics Center, 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

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Cerebral Infarction
Antilipemic Agents
Stroke
Vascular Diseases
Central Nervous System Diseases
Anticholesteremic Agents
Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Brain Diseases
Cerebrovascular Disorders
Recurrence
Pravastatin
Neoplasm Metastasis
Brain Ischemia
Brain Infarction
Infarction
Hypercholesterolemia

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Antilipemic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Brain Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cerebrovascular Disorders
Pharmacologic Actions
Pravastatin
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on May 06, 2009