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

Ercan OK

Status and phase

Completed

Phase 3

Conditions

Inflammation

Vascular Calcification

Dyslipidemia

Atherosclerosis

Treatments

Drug: atorvastatin

Drug: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00481364

06-4.1/2

Details and patient eligibility

About

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.

Full 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.

Enrollment

446 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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