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

This study is ongoing, but not recruiting participants.

First Received on August 7, 2006. Last Updated on September 12, 2011 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: Statin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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 [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

Secondary Outcome Measures:

recurrent stroke [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

Enrollment:	1095
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Pravastatin	Drug: Statin
No Intervention: No intervention

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 University Hospital
Hiroashima, Hiroshima, Japan, 734-8551
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

ClinicalTrials.gov Identifier:	NCT00361699 History of Changes
Other Study ID Numbers:	J-STARS hsCRP
Study First Received:	August 7, 2006
Last Updated:	September 12, 2011
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:

Hyperlipidemias
Ischemia
Stroke
Cerebral Infarction
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pravastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012