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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Statin

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring 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

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hiroshima University Hospital
Osaka University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pravastatin

No intervention

Arm Description

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.

Patient has no intervention.

Outcomes

Primary Outcome Measures

serum level of high sensitive CRP

Secondary Outcome Measures

recurrent stroke

Full Information

NCT ID

NCT00361699

First Posted

August 7, 2006

Last Updated

April 22, 2016

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Ministry of Health, Labour and Welfare, Japan, Hiroshima University, Osaka University

1. Study Identification

Unique Protocol Identification Number

NCT00361699

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Ministry of Health, Labour and Welfare, Japan, Hiroshima University, Osaka University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1095 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pravastatin

Arm Type

Active Comparator

Arm Description

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.

Arm Title

No intervention

Arm Type

No Intervention

Arm Description

Patient has no intervention.

Intervention Type

Drug

Intervention Name(s)

Statin

Primary Outcome Measure Information:

Title

serum level of high sensitive CRP

Time Frame

until the last day of the next February after 5-year follow-up survey

Secondary Outcome Measure Information:

Title

recurrent stroke

Time Frame

until the last day of the next February after 5-year follow-up survey

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masayasu Matsumoto, MD, PhD

Organizational Affiliation

Hiroshima University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hiroshima University Hospital

City

Hiroashima

State/Province

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Osaka University

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://jstars.umin.ne.jp

Description

Available only in Japanese

Ischemic Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial