Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study
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|ClinicalTrials.gov Identifier: NCT00384618|
Recruitment Status : Terminated
First Posted : October 6, 2006
Last Update Posted : October 6, 2006
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: pravastatin Drug: vitamin E||Phase 4|
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: 41±17 ml / min per 1.73 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 mg/day to which after 6 months vitamin E 300 mg/day was added and after another 6 months homocysteine-lowering therapy (folic acid 5 mg/day, pyridoxine 100 mg, vitamin B-12 1 mg/day). 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 < 140/90 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2001|
|Estimated Study Completion Date :||August 2005|
- Common carotid artery intima media thickness
- Brachial artery flow mediated vasodilatation
- Renal function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384618
|VU University Medical Center|
|Amsterdam, North Holland, Netherlands, 1007 MB|
|Study Director:||Prof. Peter M ter Wee, MD, PhD||Depratment of Nephrology, VU University Medical Center|