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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Ischemic Stroke

Treatments: Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT00361530

J-STARS echo

C000000212 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 854 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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854 participants in 2 patient groups

Pravastatin

Active Comparator group

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.

Treatment:

Drug: Statin

No intervention

No Intervention group

Description:

Patient has no intervention.