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Completed

NCT Number: NCT00361699

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Stroke Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hiroshima University Hospital, Hiroashima, Hiroshima, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Statin

Drug

Primary outcomes

  1. serum level of high sensitive CRP

    Time frame: until the last day of the next February after 5-year follow-up survey

Secondary outcomes

  1. recurrent stroke

    Time frame: until the last day of the next February after 5-year follow-up survey

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

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

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2014
First posted
Aug 8, 2006
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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