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

This study has been completed.

Sponsor:

Collaborators:

Ministry of Health, Labour and Welfare, Japan

Hiroshima University

National Cerebral and Cardiovascular Center

Information provided by (Responsible Party):

Translational Research Informatics Center, Kobe, Hyogo, Japan

ClinicalTrials.gov Identifier:

NCT00361530

First received: August 7, 2006

Last updated: April 22, 2016

Last verified: April 2016

History of Changes

Purpose

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.

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 Carotid Intima-media Complex Thickness in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.

Resource links provided by NLM:

MedlinePlus related topics: Statins

U.S. FDA Resources

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:

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 Outcome Measures:

Plaque score, number of plaque, recurrent cerebrovascular events [ Time Frame: until the last day of the next February after 5-year follow-up survey ]


Enrollment:	854
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


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.

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361530

Locations


Japan
National Cardiovascular Center (NCVC)
Suita-shi, Osaka, Japan, 565-0873
Hiroshima University Hospital
Hiroshima, Japan, 734-8551

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

Ministry of Health, Labour and Welfare, Japan

Hiroshima University

National Cerebral and Cardiovascular Center

Investigators


Principal Investigator:	Masayasu Matsumoto, MD, PhD	Hiroshima University Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT00361530 History of Changes
Other Study ID Numbers:	J-STARS echo C000000212 ( Other Identifier: UMIN CTR )
Study First Received:	August 7, 2006
Last Updated:	April 22, 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 plaque tunica intima tunica media ultrasonography carotid arteries

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

ClinicalTrials.gov processed this record on August 18, 2017

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