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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Statin
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring 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

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cardiovascular Center (NCVC)
  • Hiroshima University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pravastatin

No intervention

Arm Description

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.

Patient has no intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plaque score, number of plaque, recurrent cerebrovascular events

Full Information

First Posted
August 7, 2006
Last Updated
April 22, 2016
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan, Hiroshima University, National Cerebral and Cardiovascular Center, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00361530
Brief Title
Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Ministry of Health, Labour and Welfare, Japan, Hiroshima University, National Cerebral and Cardiovascular Center, Japan

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
854 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pravastatin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patient has no intervention.
Intervention Type
Drug
Intervention Name(s)
Statin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Plaque score, number of plaque, recurrent cerebrovascular events
Time Frame
until the last day of the next February after 5-year follow-up survey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masayasu Matsumoto, MD, PhD
Organizational Affiliation
Hiroshima University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiovascular Center (NCVC)
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0873
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31035902
Citation
Wada S, Koga M, Minematsu K, Toyoda K, Suzuki R, Kagimura T, Nagai Y, Aoki S, Nezu T, Hosomi N, Origasa H, Ohtsuki T, Maruyama H, Yasaka M, Kitagawa K, Uchiyama S, Matsumoto M. Baseline Carotid Intima-Media Thickness and Stroke Recurrence During Secondary Prevention With Pravastatin. Stroke. 2019 Jun;50(6):1586-1589. doi: 10.1161/STROKEAHA.119.024968. Epub 2019 Apr 30.
Results Reference
derived
PubMed Identifier
29191850
Citation
Koga M, Toyoda K, Minematsu K, Yasaka M, Nagai Y, Aoki S, Nezu T, Hosomi N, Kagimura T, Origasa H, Kamiyama K, Suzuki R, Ohtsuki T, Maruyama H, Kitagawa K, Uchiyama S, Matsumoto M; J-STARS Investigators. Long-Term Effect of Pravastatin on Carotid Intima-Media Complex Thickness: The J-STARS Echo Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Jan;49(1):107-113. doi: 10.1161/STROKEAHA.117.018387. Epub 2017 Nov 30.
Results Reference
derived
Links:
URL
http://jstars.umin.ne.jp
Description
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Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)

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