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Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Pravastatin

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

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. 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

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

Incidence Rate of Stroke and TIA

Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Secondary Outcome Measures

Incidence Rate of Atherothrombotic Infarction

Incidence rate of patients with atherothrombotic infarction

Incidence Rate of Lacunar Infarction

Incidence rate of patients with lacunar infarction

Incidence Rate of Cardioembolic Infarction

Incidence rate of patients with cardioembolic infarction

Incidence Rate of Intracranial Hemorrhage

Incidence rate of patients with intracranial hemorrhage

Full Information

NCT ID

NCT00221104

First Posted

September 13, 2005

Last Updated

June 19, 2017

Sponsor

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

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00221104

Brief Title

Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Official Title

Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 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

4. Oversight

5. Study Description

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.

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1578 (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)

Pravastatin

Primary Outcome Measure Information:

Title

Incidence Rate of Stroke and TIA

Description

Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Time Frame

up to 5 years

Secondary Outcome Measure Information:

Title

Incidence Rate of Atherothrombotic Infarction

Description

Incidence rate of patients with atherothrombotic infarction

Time Frame

up to 5 years

Title

Incidence Rate of Lacunar Infarction

Description

Incidence rate of patients with lacunar infarction

Time Frame

up to 5 years

Title

Incidence Rate of Cardioembolic Infarction

Description

Incidence rate of patients with cardioembolic infarction

Time Frame

up to 5 years

Title

Incidence Rate of Intracranial Hemorrhage

Description

Incidence rate of patients with intracranial hemorrhage

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

29511130

Citation

Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.

Results Reference

derived

PubMed Identifier

28924103

Citation

Hosomi N, Nagai Y, Kitagawa K, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS collaborators. Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event. J Atheroscler Thromb. 2018 Mar 1;25(3):262-268. doi: 10.5551/jat.40196. Epub 2017 Sep 16.

Results Reference

derived

PubMed Identifier

28135841

Citation

Nakamura M, Fukukawa T, Kitagawa K, Nagai Y, Hosomi N, Minematsu K, Uchiyama S, Matsumoto M, Miyamoto Y; for J-STARS collaborators. Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke. Ann Clin Biochem. 2018 Jan;55(1):128-135. doi: 10.1177/0004563217693651. Epub 2017 Jul 10.

Results Reference

derived

Links:

URL

http://jstars.umin.ne.jp

Description

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

Learn more about this trial

Japan Statin Treatment Against Recurrent Stroke (J-STARS)

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