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