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

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)

Overall Status

Completed

CT.gov ID

NCT00361699

Collaborator

Ministry of Health, Labour and Welfare, Japan (Other), Hiroshima University (Other), Osaka University (Other)

1,095

Enrollment

Locations

Arms

547.5

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Statin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1095 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon the Serum High Sensitive CRP in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pravastatin 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.	Drug: Statin
No Intervention: No intervention Patient has no intervention.

Arm

Intervention/Treatment

Active Comparator: Pravastatin

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.

Drug: Statin

No Intervention: No intervention

Patient has no intervention.

Outcome Measures

Primary Outcome Measures

serum level of high sensitive CRP [until the last day of the next February after 5-year follow-up survey]

Secondary Outcome Measures

recurrent stroke [until the last day of the next February after 5-year follow-up survey]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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