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

Sponsor

Chieko Hamada (Other)

Overall Status

Terminated

CT.gov ID

NCT00846118

Collaborator

(none)

905

Enrollment

Location

Arms

67.9

Actual Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Pitavastatin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

905 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jan 31, 2011

Actual Study Completion Date :

Sep 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pitavastatin Pitavastatin in addition to optimal standard care	Drug: Pitavastatin 1-4mg/day Other Names: LIVALO
No Intervention: optimal standard care

Arm

Intervention/Treatment

Active Comparator: Pitavastatin

Pitavastatin in addition to optimal standard care

Drug: Pitavastatin

1-4mg/day

Other Names:

LIVALO

No Intervention: optimal standard care

Outcome Measures

Primary Outcome Measures

all cause mortality [whole observational period]
Myocardial infarction of the new onset [whole observational period]

Secondary Outcome Measures

Cardiac death [whole observational period]
Myocardial infarction of the new onset [whole observational period]

Other Outcome Measures

interventions for ischemic heart disease [whole observational period]
Serious arrhythmia [whole observational period]
Hospitalization for the heart failure [whole observational period]
Hospitalization for the unstable angina [whole observational period]
cerebral stroke [whole observational period]
Bone fracture [whole observational period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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