hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)

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

NCT00361699

J-STARS hsCRP

C000000211 (Other Identifier)

Details and patient eligibility

About

Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.

Enrollment: 1,095 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 filled in by the patient.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,095 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.