Clinical trial NCT00361699: hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: stroke
brain ischemia
cerebrovascular accident
statin
hydroxymethylglutaryl-CoA reductase inhibitors
cholesterol
hypercholesterolemia
hyperlipidemia
multicenter studies
prospective studies
endpoint determination
randomized controlled trials
recurrence
pravastatin
c-reactive Protein
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
name: Hiroshima University
name: Osaka University
First posted: 2006-08-08
Enrollment: 1095
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: serum level of high sensitive CRP
timeFrame: until the last day of the next February after 5-year follow-up survey
Secondary outcomes:
measure: recurrent stroke
timeFrame: until the last day of the next February after 5-year follow-up survey
Other outcomes:
Locations:
city: Hiroashima
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Suita-shi
country: Japan
facility: Osaka University
state: Osaka
Study officials:
affiliation: Hiroshima University Hospital
name: Masayasu Matsumoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: