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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00846118
• Other study ID #: 208-032
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2009
• Est. completion date: September 30, 2014

Study information

• Verified date: August 2021
• Source: Juntendo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 905
• Est. completion date: September 30, 2014
• Est. primary completion date: January 31, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Pitavastatin
1-4mg/day

Locations

Country	Name	City	State
Japan	Division of Nephrology, Department of Internal Medicine, Juntendo Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Chieko Hamada

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	interventions for ischemic heart disease		whole observational period
Other	Serious arrhythmia		whole observational period
Other	Hospitalization for the heart failure		whole observational period
Other	Hospitalization for the unstable angina		whole observational period
Other	cerebral stroke		whole observational period
Other	Bone fracture		whole observational period
Primary	all cause mortality		whole observational period
Primary	Myocardial infarction of the new onset		whole observational period
Secondary	Cardiac death		whole observational period
Secondary	Myocardial infarction of the new onset		whole observational period