Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ercan OK
Collaborator:
Pfizer
Treatments:
Atorvastatin
Atorvastatin Calcium
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