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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361699
First Posted: August 8, 2006
Last Update Posted: April 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Osaka University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pravastatin
Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.
Drug: Statin
No Intervention: No intervention
Patient has no intervention.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00361699     History of Changes
Other Study ID Numbers: J-STARS hsCRP
C000000211 ( Other Identifier: UMIN CTR )
First Submitted: August 7, 2006
First Posted: August 8, 2006
Last Update Posted: April 25, 2016
Last Verified: April 2016

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:
Stroke
Ischemia
Hyperlipidemias
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents