Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study
Status:
Terminated
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
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 (>3gr/24hr urine protein), renal transplantation, fasting total
cholesterol > 7 mmol/L, 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.
Phase:
Phase 4
Details
Lead Sponsor:
VU University Medical Center
Collaborators:
Bristol-Myers Squibb Medical Research Foundation, The Netherlands
Treatments:
alpha-Tocopherol Pravastatin Tocopherols Tocotrienols Vitamin E Vitamins