Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)
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.
2 other identifiers
interventional
854
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 7, 2006
CompletedFirst Posted
Study publicly available on registry
August 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedApril 25, 2016
April 1, 2016
10.3 years
August 7, 2006
April 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intima-media complex thickness (IMT) of the common carotid artery (CCA)
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
until the last day of the next February after 5-year follow-up survey
Study Arms (2)
Pravastatin
ACTIVE COMPARATORPatient 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.
No intervention
NO INTERVENTIONPatient has no intervention.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
National Cardiovascular Center (NCVC)
Suita-shi, Osaka, 565-0873, Japan
Related Publications (3)
Wada S, Koga M, Kagimura T, Toyoda K, Nagai Y, Aoki S, Nezu T, Hosomi N, Origasa H, Ohtsuki T, Maruyama H, Yasaka M, Kitagawa K, Uchiyama S, Minematsu K, Matsumoto M; Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study Collaborators. Long-term changes in carotid intima-media thickness according to baseline blood pressure level: J-STARS Echo study. J Neurol Sci. 2025 Jan 15;468:123342. doi: 10.1016/j.jns.2024.123342. Epub 2024 Dec 9.
PMID: 39673820DERIVEDWada 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.
PMID: 31035902DERIVEDKoga 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.
PMID: 29191850DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masayasu Matsumoto, MD, PhD
Hiroshima University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2006
First Posted
August 8, 2006
Study Start
March 1, 2004
Primary Completion
July 1, 2014
Last Updated
April 25, 2016
Record last verified: 2016-04