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| Descriptive Information Fields | |||||||||
| 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. | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | serum level of high sensitive CRP | ||||||||
| Secondary Outcome Measure † | recurrent stroke | ||||||||
| Condition † | Ischemic Stroke | ||||||||
| Intervention † | Drug: Pravastatin | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Available only in Japanese ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 1200 | ||||||||
| Start Date † | March 2004 | ||||||||
| Completion Date | February 2014 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 45 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Japan | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00361699 | ||||||||
| Organization ID | J-STARS hsCRP | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Translational Research Informatics Center, Kobe, Hyogo, Japan | ||||||||
| Collaborators †† | Japanese Ministry of Health, Labor and Welfare Hiroshima University Osaka University |
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| Investigators † |
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| Information Provided By | Translational Research Informatics Center, Kobe, Hyogo, Japan | ||||||||
| Verification Date | June 2007 | ||||||||
| First Received Date † | August 7, 2006 | ||||||||
| Last Updated Date | June 15, 2007 | ||||||||