hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)

This study is ongoing, but not recruiting participants.

First Received: August 7, 2006 Last Updated: July 1, 2009 History of Changes

Sponsor:	Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators:	Ministry of Health, Labour and Welfare, Japan Hiroshima University Osaka University
Information provided by:	Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT00361699

Purpose

Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.

Condition	Intervention	Phase
Ischemic Stroke	Drug: Pravastatin	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of 3-Hydroxy-3-Methylglutaryl-Coenzyme A(HMG-CoA) Reductase Inhibitor Upon the Serum High Sensitive CRP in the Post-Ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

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

Primary Outcome Measures:

serum level of high sensitive CRP

Secondary Outcome Measures:

recurrent stroke

Estimated Enrollment:	1200
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 filled in by the patient.

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: NCT00361699

Locations

Japan, Hiroshima
Hiroshima University Hospital
Hiroashima, Hiroshima, Japan, 734-8551
Japan, Osaka
Osaka University
Suita-shi, Osaka, Japan, 565-0871

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

Ministry of Health, Labour and Welfare, Japan

Hiroshima University

Osaka University

Investigators

Principal Investigator:

Masayasu Matsumoto, MD, PhD

Hiroshima University Hospital

More Information

Additional Information:

Available only in Japanese This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	J-STARS hsCRP
Study First Received:	August 7, 2006
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00361699 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
c-reactive Protein

Additional relevant MeSH terms:

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

Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Pravastatin
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009