- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481364
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Izmir
-
Bornova, Izmir, Turkey, 35100
- Ege University School of Medicine, Division of Nephrology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
placebo
|
1 tb/day
|
Active Comparator: Statin
Atorvastatin 40 mg/day
|
atorvastatin 40 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression of coronary artery calcification score
Time Frame: one year
|
one year
|
progression of carotid artery intima-media thickness
Time Frame: one year
|
one year
|
changes in the level of hsCRP
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in the level of hsCRP
Time Frame: one year
|
one year
|
changes in the endothelial function
Time Frame: one year
|
one year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Vascular Diseases
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Lipid Metabolism Disorders
- Calcium Metabolism Disorders
- Cardiovascular Diseases
- Inflammation
- Dyslipidemias
- Atherosclerosis
- Calcinosis
- Vascular Calcification
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 06-4.1/2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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