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

Tracking Information

First Received Date ^ICMJE

August 7, 2006

Last Updated Date

July 1, 2009

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

serum level of high sensitive CRP

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00361699 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

recurrent stroke

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ischemic Stroke

Intervention ^ICMJE

Drug: Pravastatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1200

Estimated Completion Date

February 2014

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00361699

Responsible Party

Study ID Numbers ^ICMJE

J-STARS hsCRP

Study Sponsor ^ICMJE

Translational Research Informatics Center, Kobe, Hyogo, Japan

Collaborators ^ICMJE

Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Osaka University

Investigators ^ICMJE

Principal Investigator:

Masayasu Matsumoto, MD, PhD

Hiroshima University Hospital

Information Provided By

Translational Research Informatics Center, Kobe, Hyogo, Japan

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP