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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ege University
ClinicalTrials.gov Identifier:
NCT00481364
First received: May 30, 2007
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 446
Study Start Date: November 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Atorvastatin 40 mg/day
 Drug: atorvastatin
atorvastatin 40 mg/day
Placebo Comparator: 2
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
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

No publications provided

Responsible Party: Ege University, Prof.Dr.Ercan Ok, Ege University Division of Nephrology
ClinicalTrials.gov Identifier: NCT00481364     History of Changes
Other Study ID Numbers: 06-4.1/2
Study First Received: May 30, 2007
Last Updated: August 3, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Ege University:
hemodialysis
endothelial function
coronary artery calcification
atherosclerosis
statin

Additional relevant MeSH terms:
Atherosclerosis
Calcinosis
Cardiovascular Diseases
Inflammation
Dyslipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Pathologic Processes
 Lipid Metabolism Disorders
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013