Clinical trial NCT00846118: Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)
Official title: Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Pitavastatin
Hemodialysis
Mortality
Cardiovascular disease
Lead sponsor: Juntendo University
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 905
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: all cause mortality
timeFrame: whole observational period
measure: Myocardial infarction of the new onset
timeFrame: whole observational period
Secondary outcomes:
measure: Cardiac death
timeFrame: whole observational period
measure: Myocardial infarction of the new onset
timeFrame: whole observational period
Other outcomes:
measure: interventions for ischemic heart disease
timeFrame: whole observational period
measure: Serious arrhythmia
timeFrame: whole observational period
measure: Hospitalization for the heart failure
timeFrame: whole observational period
measure: Hospitalization for the unstable angina
timeFrame: whole observational period
measure: cerebral stroke
timeFrame: whole observational period
measure: Bone fracture
timeFrame: whole observational period
Locations:
city: Tokyo
country: Japan
facility: Division of Nephrology, Department of Internal Medicine, Juntendo Hospital
Study officials:
affiliation: Professor of Medicine, Department of Nephrology, Juntendo University Graduate School of Medicine
name: Yasuhiko Tomino, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: