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

Chieko Hamada

Status

Terminated

Conditions

Cardiovascular Disease

Treatments

Drug: Pitavastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00846118

208-032

Details and patient eligibility

About

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

Full 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.

Enrollment

905 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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