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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361530

Enrollment

854

Registered

2006-08-08

Start date

2004-03-31

Completion date

Unknown

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGStatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Plaque score, number of plaque, recurrent cerebrovascular events	until the last day of the next February after 5-year follow-up survey

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026