Japan Statin Treatment Against Recurrent Stroke (J-STARS)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborators: Hiroshima University; Ministry of Health, Labour and Welfare, Japan
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin

Criteria

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