Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
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
Osaka University
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 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