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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00361699

Enrollment

1095

Registered

2006-08-08

Start date

2004-03-31

Completion date

Unknown

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGStatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
serum level of high sensitive CRP	until the last day of the next February after 5-year follow-up survey

Secondary

Measure	Time frame
recurrent stroke	until the last day of the next February after 5-year follow-up survey

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026