Cardiovascular Disease
Conditions
Keywords
Pitavastatin, Hemodialysis, Mortality, Cardiovascular disease
Brief summary
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
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.
Interventions
DRUGPitavastatin
1-4mg/day
Sponsors
Chieko Hamada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality | whole observational period |
| Myocardial infarction of the new onset | whole observational period |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac death | whole observational period |
| Myocardial infarction of the new onset | whole observational period |
Other
| Measure | Time frame |
|---|---|
| cerebral stroke | whole observational period |
| interventions for ischemic heart disease | whole observational period |
| Bone fracture | whole observational period |
| Serious arrhythmia | whole observational period |
| Hospitalization for the heart failure | whole observational period |
| Hospitalization for the unstable angina | whole observational period |
Countries
Japan
Outcome results
None listed