Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)
This study is ongoing, but not recruiting participants.
Sponsor:
Translational Research Informatics Center, Kobe, Hyogo, Japan
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: May 13, 2014
Last verified: May 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| Enrollment: | 854 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | July 2014 |
| Estimated 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 |
| Genders Eligible for Study: | Both |
| 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
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:
No publications provided
| Responsible Party: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
| ClinicalTrials.gov Identifier: | NCT00361530 History of Changes |
| Other Study ID Numbers: | J-STARS echo, C000000212 |
| Study First Received: | August 7, 2006 |
| Last Updated: | May 13, 2014 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |
ClinicalTrials.gov processed this record on March 03, 2015