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Completed

NCT Number: NCT00361530

Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)

Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in the patients with prescription of pravastatin and the control.

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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, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid 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, 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.

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
  • Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis
  • Patients after carotid endarterectomy or radiation therapy to neck
  • Patients whose carotid ultrasound cannot be examined because of neck tumor or torticollis
  • Patients after carotid endarterectomy or radiation therapy to neck

Treatment and study plan

Statin

Drug

Primary outcomes

  1. Intima-media complex thickness (IMT) of the common carotid artery (CCA)

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

Secondary outcomes

  1. Plaque score, number of plaque, recurrent cerebrovascular events

    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
  • National Cerebral and Cardiovascular Center, Japan

Registry information

Official study title

Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon Carotid Intima-media Complex Thickness 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.

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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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