Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384618
Status:
TERMINATED
Last Update Posted:
2006-10-06
First Post:
2006-10-04
Brief Title:
Anti-Oxidant Therapy In Chronic Renal Insufficiency ATIC Study
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Effect of an Oxidative-Stress-Reducing Strategy Consisting of Pravastatin Vitamin E and Homocysteine-Lowering on Carotid Intima-Media Thickness in Patients With Mild-to-Moderate Chronic Kidney Disease
Status:
TERMINATED
Status Verified Date:
2006-10
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:
The ATIC study is a randomised double- blind placebo-controlled trial in which the effects of oxidative stress-lowering treatment on vascular function and structure are studied in patients with chronic non-diabetic renal failure who are free from manifest arterial occlusive disease Participants in the trial were randomised to active treatment consisting of add-on therapy with pravastatin vitamin E and homocysteine-lowering therapy or to placebo Subjects not using angiotensin converting enzyme inhibitors ACE-inhibitors or angiotensin receptor blockers ARBs at inclusion were put on ACE-inhibitors for at least two weeks before the baseline measurement and randomisation Those who were on ARBs continued their ARBs We excluded individuals with diabetes mellitus ADA criteria active vasculitis nephrotic syndrome 3gr24hr urine protein renal transplantation fasting total cholesterol 7 mmolL cholesterol-lowering therapy within three months prior to inclusion or known ischemic cardiac cerebrovascular or peripheral arterial disease Ninety-three patients out of 118 eligible patients took part in the study and written informed consent was obtained from all participants
Detailed Description:
Background Patients with mild-to-moderate renal failure have an increased risk of cardiovascular disease CVD which is not fully explained by the presence of classical cardiovascular risk factors Oxidative stress has been proposed to play a major role in the development of CVD among renal failure patients We investigated in patients with mild-to-moderate chronic kidney disease CKD the effect of an oxidative-stress-lowering therapy with pravastatin vitamin E and homocysteine-lowering on carotid intima-media thickness and endothelial function two strong surrogate markers of cardiovascular risk and renal function
Methods 93 patients with CKD Cockcroft-Gault equation mean 4117 ml min per 173 m2 who were free of manifest arterial occlusive disease and diabetes mellitus were included in the Anti-oxidant Therapy In Chronic renal insufficiency ATIC study a randomized double-blind placebo-controlled trial The active treatment group received pravastatin 40 mgday to which after 6 months vitamin E 300 mgday was added and after another 6 months homocysteine-lowering therapy folic acid 5 mgday pyridoxine 100 mg vitamin B-12 1 mgday The placebo group received matching placebos at onset and 6 and 12 months later Blood pressure in both groups was managed according to a standard protocol to achieve a blood pressure of 14090 mmHg Patients were followed up for two years Measurements of common carotid artery intima-media thickness CCA-IMT and brachial artery endothelium-dependent flow-mediated dilatation BA-FMD were performed at randomisation and after 6 12 and 18 months Plasma oxidized LDL oxLDL and plasma malondialdehyde MDA were measured as markers of oxidative stress at randomisation and after 6 12 18 and 24 months We used generalized estimating equations GEE for data analysis
Methods 93 patients with CKD Cockcroft-Gault equation mean 4117 ml min per 173 m2 who were free of manifest arterial occlusive disease and diabetes mellitus were included in the Anti-oxidant Therapy In Chronic renal insufficiency ATIC study a randomized double-blind placebo-controlled trial The active treatment group received pravastatin 40 mgday to which after 6 months vitamin E 300 mgday was added and after another 6 months homocysteine-lowering therapy folic acid 5 mgday pyridoxine 100 mg vitamin B-12 1 mgday The placebo group received matching placebos at onset and 6 and 12 months later Blood pressure in both groups was managed according to a standard protocol to achieve a blood pressure of 14090 mmHg Patients were followed up for two years Measurements of common carotid artery intima-media thickness CCA-IMT and brachial artery endothelium-dependent flow-mediated dilatation BA-FMD were performed at randomisation and after 6 12 and 18 months Plasma oxidized LDL oxLDL and plasma malondialdehyde MDA were measured as markers of oxidative stress at randomisation and after 6 12 18 and 24 months We used generalized estimating equations GEE for data analysis
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