Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)

Study Overview
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Brief Summary
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The purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.

Detailed Description
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It was already proved by the clinical trials that statins prevent from death and cardiovascular events. However, the efficacy of statins in patients with chronic hemodialysis has not been proved yet.

Official Title
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Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Pitavastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients under hemodialysis patients with hypercholesterolemia as defined by any of following parameters: LDL-C ≧ 100 mg / dL TC ≧ 180 mg / dL patients required cholesterol-lowering treatment by investigators. patients aged 20-75 years patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial Exclusion Criteria: patients taking statins or fibrates patients enrolled to the other trials using contraindication drugs of pitavastatin patients who had acute myocardial infarction within six months before the day of the agreement acquisition patients scheduled PCI and CABG within six months after the day of the agreement acquisition Patients who had diagnosis or doubt of malignant tumor patients corresponded to Contraindications of pitavastatin Familial hypercholesterolemia patients patients judged ineligible by investigators

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pitavastatin<br>Pitavastatin in addition to optimal standard care | Drug: Pitavastatin<br>* 1-4mg/day<br>* Other names: LIVALO;|
| No Intervention: optimal standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | whole observational period | 
| Myocardial infarction of the new onset |  | whole observational period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | whole observational period | 
| Myocardial infarction of the new onset |  | whole observational period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pitavastatin, Hemodialysis, Mortality, Cardiovascular disease