hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
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
Osaka University
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00361699
First received: August 7, 2006
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke |
Drug: Statin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Primary Outcome Measures:
- serum level of high sensitive CRP [ Time Frame: until the last day of the next February after 5-year follow-up survey ]
Secondary Outcome Measures:
- recurrent stroke [ Time Frame: until the last day of the next February after 5-year follow-up survey ]
| Enrollment: | 1095 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Pravastatin | Drug: Statin |
| No Intervention: 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361699
Locations
| Japan | |
| Hiroshima University Hospital | |
| Hiroashima, Hiroshima, Japan, 734-8551 | |
| Osaka University | |
| Suita-shi, Osaka, Japan, 565-0871 | |
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Osaka University
Investigators
| Principal Investigator: | Masayasu Matsumoto, MD, PhD | Hiroshima University Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00361699 History of Changes |
| Other Study ID Numbers: | J-STARS hsCRP |
| Study First Received: | August 7, 2006 |
| Last Updated: | December 12, 2012 |
| 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 c-reactive Protein |
Additional relevant MeSH terms:
|
Hyperlipidemias Ischemia Stroke Cerebral Infarction Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Brain Infarction Brain Ischemia Pravastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013