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

Not Applicable

Terminated

• Conditions: Cardiovascular Disease
• Interventions: Drug: Pitavastatin

• Registration Number: NCT00846118
• Lead Sponsor: Chieko Hamada

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.

Study Timeline

• Study Start: 2009-02-01
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2011-01-31
• Study Completion: 2014-09-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 905

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin	Pitavastatin	Pitavastatin in addition to optimal standard care

Primary Outcome Measures

Name	Time	Method
all cause mortality	whole observational period
Myocardial infarction of the new onset	whole observational period

Secondary Outcome Measures

Name	Time	Method
Cardiac death	whole observational period
Myocardial infarction of the new onset	whole observational period

Trial Locations

Locations (1)

Division of Nephrology, Department of Internal Medicine, Juntendo Hospital; 🇯🇵 Tokyo, Japan