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Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481364
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):
Ercan OK, Ege University

Brief Summary:
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 or disease Intervention/treatment Phase
Vascular Calcification Atherosclerosis Dyslipidemia Inflammation Drug: atorvastatin Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
Study Start Date : November 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Statin
Atorvastatin 40 mg/day
Drug: atorvastatin
atorvastatin 40 mg/day
Placebo Comparator: Placebo
Drug: placebo
1 tb/day

Primary Outcome Measures :
  1. progression of coronary artery calcification score [ Time Frame: one year ]
  2. progression of carotid artery intima-media thickness [ Time Frame: one year ]
  3. changes in the level of hsCRP [ Time Frame: one year ]

Secondary Outcome Measures :
  1. changes in the endothelial function [ Time Frame: one year ]
  2. changes in the level of hsCRP [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481364

Ege University School of Medicine, Division of Nephrology
Bornova, Izmir, Turkey, 35100
Sponsors and Collaborators
Ercan OK
Principal Investigator: Ercan Ok, MD Ege University, Division of Nephrology

Responsible Party: Ercan OK, professor, Ege University Identifier: NCT00481364     History of Changes
Other Study ID Numbers: 06-4.1/2
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

Keywords provided by Ercan OK, Ege University:
endothelial function
coronary artery calcification

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Calcification
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Calcium Metabolism Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors