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

Phase 3

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Statin

• Registration Number: NCT00361530
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-08
• Primary Completion: 2014-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 854

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pravastatin	Statin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Hiroshima University Hospital; 🇯🇵 Hiroshima, Japan

National Cardiovascular Center (NCVC); 🇯🇵 Suita-shi, Osaka, Japan