Japan Statin Treatment Against Recurrent Stroke (J-STARS)
This study is ongoing, but not recruiting participants.
Sponsor:
Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00221104
First received: September 13, 2005
Last updated: May 13, 2014
Last verified: May 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke |
Drug: Pravastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke |
Resource links provided by NLM:
Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Primary Outcome Measures:
- cerebrovascular events [ Time Frame: until the last day of the next February after 5-year follow-up survey ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- subtype of ischemic stroke according to the TOAST classification or hemorrhagic stroke, cardiovascular events including myocardial infarction, all the cerebrovascular and cardiovascular events, death of stroke, death of cerebrovascular and cardiovascular [ Time Frame: until the last day of the next February after 5-year follow-up survey ] [ Designated as safety issue: No ]
| Enrollment: | 1578 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Drug: Pravastatin |
|
No Intervention: No intervention
Patient has no intervention.
|
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00221104
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221104
Locations
| Japan | |
| Hiroshima University | |
| Hiroshima, Japan, 734-8551 | |
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Investigators
| Principal Investigator: | Masayasu Matsumoto, MD, PhD | Hiroshima University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Translational Research Informatics Center, Kobe, Hyogo, Japan |
| ClinicalTrials.gov Identifier: | NCT00221104 History of Changes |
| Other Study ID Numbers: | J-STARS, C000000207 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 13, 2014 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
|
stroke brain ischemia cerebrovascular accident statin hydroxymethylglutaryl-CoA reductase inhibitors cholesterol hypercholesterolemia |
hyperlipidemia multicenter studies prospective studies endpoint determination randomized controlled trials recurrence pravastatin |
Additional relevant MeSH terms:
|
Pravastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015