Principle Investigator:
Bradley S. Dixon, M.D.
Study ends:
3/01/2007
Purpose:
To determine whether the study medication Aggrenox started after creation of a new arteriovenous graft access for hemodialysis will prevent the access narrowing and clotting that leads to graft failure.
Overview:
An arteriovenous graft access is a surgically created connection of artery to vein using a hollow tube or “graft” which allows needles to be placed to remove blood for hemodialysis. The arteriovenous graft is often usable for dialysis very soon after surgery but has the problem that inflammation at the graft-vein connection leads to access narrowing and clotting which leads to graft failure. This multicenter trial will test whether the medication Aggrenox (which contains both dipyridamole and a low dose of aspirin) will prevent graft failure. Participants will be enrolled prior to access surgery. Following creation of the arteriovenous graft, participants will be randomly assigned to treatment with either Aggrenox 1 capsule twice a day or a matched placebo starting within 2 days after the surgery. Neither the study doctor nor the participant will know which medication they are taking. Participants will be followed monthly to determine whether their access is open and working. The primary study goal is to determine how long the access remains open without clotting or requiring a procedure to correct a severe narrowing. The study medication is continued until this endpoint is reached or the study ends.
Eligibility:
Patients 18 years of age or older with chronic renal failure who are on chronic hemodialysis or anticipated to begin chronic hemodialysis within 6 months are eligible to participate. Patients who already require treatment with clopidogrel or Warfarin or who have a serious bleeding disorder or other medical condition that precludes use of Aggrenox are not eligible for enrollment.
Sponsor:
National Institutes of Health / National Institutes of Diabetes and Digestive and Kidney Diseases.
Contact Info:
For further information please contact Mr. Bradley Franzwa at 319-353-6689.
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