Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients - Full Text View

Sponsors and Collaborators:	Ege University Pfizer
Information provided by:	Ege University
ClinicalTrials.gov Identifier:	NCT00481364

Purpose

This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation.

Condition	Intervention	Phase
Vascular Calcification Atherosclerosis Dyslipidemia Inflammation	Drug: atorvastatin Drug: placebo	Phase III

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study

Further study details as provided by Ege University:

Primary Outcome Measures:

progression of coronary artery calcification score [ Time Frame: one year ] [ Designated as safety issue: No ]
progression of carotid artery intima-media thickness [ Time Frame: one year ] [ Designated as safety issue: No ]
changes in the level of hsCRP [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

changes in the endothelial function [ Time Frame: one year ] [ Designated as safety issue: No ]
changes in the level of hsCRP [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	446
Study Start Date:	November 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Atorvastatin 40 mg/day	Drug: atorvastatin atorvastatin 40 mg/day
2: Placebo Comparator placebo	Drug: placebo 1 tb/day

Detailed Description:

The effects of statin treatment on coronary artery calcifications, carotid artery intima-media thickness, and endothelial functions have never been investigated in hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are derived from small studies with short follow-up.

We postulate that atorvastatin would reduce progression of coronary calcification and carotid artery intima-media thickness, decrease inflammation, and improve endothelial function.

In this prospective, controlled, randomized study, four hundred forty-six prevalent hemodialysis patients who meet inclusion and exclusion criteria will be randomized to atorvastatin(20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms (each arm consists of 223 patients), after completion of baseline investigations. Randomization will be performed with random permuted blocks and will be stratified according to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use, and dialysate calcium level. Follow-up period will be twelve months.

It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate of 5%, of detecting a significant difference between treatment arms. Dropout rate is expected to be 20%, not to be replaced.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

aged between 18 and 80 years
on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
willingness to participate to the study with a written informed consent

Exclusion Criteria:

to have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
to be scheduled for living donor renal transplantation
pregnancy or lactating
history of coronary bypass grafting, acute myocardial infarction or unstable angina pectoris confirmed by angiography within three months of randomization
presence of an absolute indication to use lipid lowering drug or an absolute contraindication for lipid lowering therapy according to investigator's opinion
history of statin sensitivity or adverse reaction to statins
receiving any lipid-lowering agents within three months of randomization
uncontrolled hypothyroidism defined as TSH level higher than 1.5 times of upper limit
receipt of any investigational drug within 30 days before randomization
inability to tolerate oral medication or history of significant malabsorption
treatment with steroids or immunosuppressive drugs
alcohol abuse, drug abuse
ALT and/or AST levels more than three times above the upper limit of normal or symptomatic hepatobiliary disease
unexplained CK> 3 times the upper limit of the normal range
inability to give informed consent because of mental incompetence or a psychiatric disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481364

Locations

Turkey, Izmir
Ege University School of Medicine, Division of Nephrology
Bornova, Izmir, Turkey, 35100

Sponsors and Collaborators

Ege University

Pfizer

Investigators

Principal Investigator:

Ercan Ok, MD

Ege University, Division of Nephrology

More Information

Responsible Party:	Prof.Dr.Ercan Ok, Ege University Division of Nephrology ( Ege University )
Study ID Numbers:	06-4.1/2
Study First Received:	May 30, 2007
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00481364
Health Authority:	Turkey: Ministry of Health

Keywords provided by Ege University:

hemodialysis
endothelial function
coronary artery calcification
atherosclerosis
statin

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Metabolic Diseases
Vascular Diseases
Disease Progression
Arteriosclerosis

Metabolic disorder
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders
Inflammation

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 06, 2009