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

Ischemic Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361530
• Other study ID #: J-STARS echo
• Secondary ID: C000000212
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2006
• Last updated: April 22, 2016
• Start date: March 2004

Study information

• Verified date: April 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 854
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• Statin

Locations

Country	Name	City	State
Japan	Hiroshima University Hospital	Hiroshima
Japan	National Cardiovascular Center (NCVC)	Suita-shi	Osaka

Sponsors (4)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Hiroshima University, Ministry of Health, Labour and Welfare, Japan, National Cerebral and Cardiovascular Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plaque score, number of plaque, recurrent cerebrovascular events		until the last day of the next February after 5-year follow-up survey	No

External Links

•   Link