Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)
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ClinicalTrials.gov Identifier: NCT00361530 |
Recruitment Status :
Completed
First Posted : August 8, 2006
Last Update Posted : April 25, 2016
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Drug: Statin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 854 participants |
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. |
Study Start Date : | March 2004 |
Actual Primary Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Statin |
No Intervention: No intervention
Patient has no intervention.
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- 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 ]
- Plaque score, number of plaque, recurrent cerebrovascular events [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00361530
Japan | |
National Cardiovascular Center (NCVC) | |
Suita-shi, Osaka, Japan, 565-0873 | |
Hiroshima University Hospital | |
Hiroshima, Japan, 734-8551 |
Principal Investigator: | Masayasu Matsumoto, MD, PhD | Hiroshima University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
ClinicalTrials.gov Identifier: | NCT00361530 |
Other Study ID Numbers: |
J-STARS echo C000000212 ( Other Identifier: UMIN CTR ) |
First Posted: | August 8, 2006 Key Record Dates |
Last Update Posted: | April 25, 2016 |
Last Verified: | April 2016 |
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 |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |