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

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

This study is currently recruiting participants.
Verified by Translational Research Informatics Center, Kobe, Hyogo, Japan, June 2007

Sponsors and Collaborators:	Translational Research Informatics Center, Kobe, Hyogo, Japan Japanese Ministry of Health, Labor and Welfare 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

ChemIDplus related topics:

Pravastatin Pravastatin sodium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

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.

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

Contacts


Contact: Masayasu Matsumoto, MD, PhD	+81-82-257-5201	mack@hiroashima-u.ac.jp

Contact: Tatsuo Kohriyama, MD, PhD	+81-82-257-5201	jstars-office@umin.ac.jp

Locations


Japan, Hiroshima
	Hiroshima University Hospital	Recruiting
	Hiroashima, Hiroshima, Japan, 734-8551
	Contact: Masayasu Matsumoto, MD, PhD +81-82-257-5201 mack@hiroshima-u.ac.jp
	Contact: Tatsuo Kohriyama, MD, PhD +81-82-257-5201 jstars-office@umin.ac.jp

Japan, Osaka
	Osaka University	Recruiting
	Suita-shi, Osaka, Japan, 565-0871
	Contact: Kazuo Kitagawa, MD, PhD +81-6-6879-3634 kitagawa@medone.med.osaka-u.ac.jp

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

Japanese Ministry of Health, Labor and Welfare

Hiroshima University

Osaka University

Investigators


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

More Information

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

Study ID Numbers:	J-STARS hsCRP
First Received:	August 7, 2006
Last Updated:	June 15, 2007
ClinicalTrials.gov Identifier:	NCT00361699
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

Study placed in the following topic categories:

Hyperlipidemias

Metabolic Diseases

Cerebral Infarction

Stroke

Vascular Diseases

Central Nervous System Diseases

Ischemia

Brain Diseases

Cerebrovascular Disorders

Recurrence

Pravastatin

Brain Ischemia

Metabolic disorder

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Nervous System Diseases

Enzyme Inhibitors

Cardiovascular Diseases

Nutritional and Metabolic Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on May 14, 2008