Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Phase 3

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Pravastatin

• Registration Number: NCT00221104
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2014-07
• Results First Submitted: 2016-07-06
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Results First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1578

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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pravastatin	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.

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Stroke and TIA	up to 5 years	Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Secondary Outcome Measures

Name	Time	Method
Incidence Rate of Lacunar Infarction	up to 5 years	Incidence rate of patients with lacunar infarction
Incidence Rate of Cardioembolic Infarction	up to 5 years	Incidence rate of patients with cardioembolic infarction
Incidence Rate of Intracranial Hemorrhage	up to 5 years	Incidence rate of patients with intracranial hemorrhage
Incidence Rate of Atherothrombotic Infarction	up to 5 years	Incidence rate of patients with atherothrombotic infarction

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan