Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481364
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2007-05-30
Brief Title:
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
Sponsor:
Ercan OK
Organization:
Ege University
Study Overview
Official Title:
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mgday in first month increased to 40 mgday 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
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 mgday in first month increased to 40 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None